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CompletedNCT01802151Updated Dec 17, 2015Results posted

Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults

An interventional study of B. subtilis R0179 and Placebo in Healthy, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-17.

Sponsored by University of Florida · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of three doses of the probiotic B. subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general wellness in healthy young adults, survival through the gastrointestinal tract and impact on intestinal microbes.

Read the detailed description

A 6 week randomized, double blind placebo controlled trial in healthy young adults aged 18 to 50. Participants will be administered an oral dose of B. subtilis or placebo (1 capsule/day) for a period of 4 weeks. Viable counts will be measured from stool samples to assess transit survival, daily questionnaires (DQ) will be administered to assess general wellness, and gastrointestinal (GI) symptoms will be evaluated three times with the Gastrointestinal Symptom Response Scale (GSRS) questionnaire.

02

Conditions studied

  • Healthy

Keywords

  • probiotics
  • microbiota
  • survival
  • gastrointestinal
  • wellness
03

In context

Lead sponsor

University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.

Browse University of Florida studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: Participants

  • Are 18-50 years of age
  • Are willing and able to complete the Informed Consent Form in English
  • Are willing to complete the GPAQ (Global Physical Activity Questionnaire) at baseline and during the last week of the study as well as completing the GSRS (Gastrointestinal Symptom Response Survey) questionnaire at baseline, during treatment and post treatment
  • Are currently "moderately active" as determined by the GPAQ (Global Physical Activity Questionnaire)
  • Are willing to have height and weight measured and to provide demographic information (age, race, sex)
  • Are willing to consume B. subtilis R0179 (approximate doses of 1, 10, or 0.1 billion CFU per day) or placebo for a 28 day period by capsule (1 per day)
  • Are willing to complete daily questionnaires regarding general and gastrointestinal wellness for the duration of the study
  • Are willing to provide 1 stool at baseline, 1 stool during week 4 of the treatment and 1 stool after 7 days of washout
  • Are willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide social security number, but no financial reimbursement can be provided
  • Are willing to have internet access for the duration of the study

Exclusion Criteria: Potential Participants will be excluded if they

  • Do not meet the inclusion criteria
  • Are currently taking medications for constipation or diarrhea
  • Have taken antibiotics within the past four weeks prior to randomization
  • Are currently taking probiotics supplements and do not want to discontinue a minimum of two weeks prior to the study
  • Known to have or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), other chronic diseases (diabetes, kidney disease, etc.) or immune-compromising diseases or conditions (HIV, AIDS, autoimmune, hepatitis, cancer, transplant patient etc.)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
83 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.

    Dietary Supplement: Placebo

  • Experimental
    B. subtilis R0179 (10 billion CFU)

    B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks. \* CFU (Colony Forming Unit)

    Dietary Supplement: B. subtilis R0179

  • Experimental
    B. subtilis R0179 (1 billion CFU)

    B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.

    Dietary Supplement: B. subtilis R0179

  • Experimental
    B. subtilis R0179 (0.1 billion CFU)

    B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.

    Dietary Supplement: B. subtilis R0179

Interventions

  • Dietary supplementB. subtilis R0179

    B. subtilis R0179 for a period of 4 weeks. One capsule per day.

  • Dietary supplementPlacebo

    Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.

06

What researchers measure

Primary outcomes

  1. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

    Time frame: Weekly for 6 weeks

  2. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

    Time frame: Weekly for 6 weeks

  3. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

    Time frame: Weekly for 6 weeks

  4. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

    Time frame: Weekly for 6 weeks

  5. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

    Time frame: Weekly for 6 weeks

  6. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

    Time frame: Weekly for 6 weeks

  7. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

    Time frame: Weekly for 6 weeks

  8. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

    Time frame: Weekly for 6 weeks

  9. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

    Time frame: Weekly for 6 weeks

  10. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

    Time frame: Weekly for 6 weeks

  11. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

    Time frame: Weekly for 6 weeks

  12. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep

    Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire.

    Time frame: Weekly for 6 weeks

  13. Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires

    Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort).

    Time frame: Weeks 1, 5, and 6

Secondary outcomes

  1. Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)

    Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p\<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g).

    Time frame: 6 weeks

07

Results

Posted Dec 17, 2015

Participant flow

Healthy adults were recruited by flyers and word of mouth on the University of Florida campus. Rolling recruitment (7/02/2012-08/23/2012) occurred until the minimum number of participants (n=80) had been enrolled.

Participant flow — Overall Study
MilestonePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Started20212220
Completed20212020
Not completed0020

Outcome measures

PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

Time frame:
Weekly for 6 weeks
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (GI Distress) Week 10.5 ± 0.80.3 ± 0.10.6 ± 0.10.7 ± 0.1
Daily Questionnaire (GI Distress) Week 20.5 ± 0.10.4 ± 0.10.6 ± 0.10.5 ± 0.1
Daily Questionnaire (GI Distress) Week 30.6 ± 0.10.3 ± 0.10.6 ± 0.10.6 ± 0.1
Daily Questionnaire (GI Distress) Week 40.6 ± 0.10.3 ± 0.010.7 ± 0.10.7 ± 0.1
Daily Questionnaire (GI Distress) Week 50.6 ± 0.10.3 ± 0.10.7 ± 0.10.5 ± 0.1
Daily Questionnaire (GI Distress) Week 60.5 ± 0.10.3 ± 0.10.6 ± 0.10.4 ± 0.1
SecondaryEvaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)

Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p\<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g).

Time frame:
6 weeks
Reported as:
Mean · log CFU/g
Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)
log CFU/gPlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
GI Viability of Bacillus Spores Week 10.9 ± 0.10.9 ± 0.10.9 ± 0.11.2 ± 0.2
GI Viability of Bacillus Spores Week 51.1 ± 0.14.6 ± 0.15.6 ± 0.16.4 ± 0.1
GI Viability of Bacillus Spores Week 61.6 ± 0.11.3 ± 0.20.8 ± 0.12.1 ± 0.1
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

Time frame:
Weekly for 6 weeks
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (Cephalic) Week 10.2 ± 0.10.2 ± 0.10.2 ± 0.040.2 ± 0.1
Daily Questionnaire (Cephalic) Week 20.2 ± 0.10.2 ± 0.10.1 ± 0.040.2 ± 0.1
Daily Questionnaire (Cephalic) Week 30.2 ± 0.10.2 ± 0.10.1 ± 0.040.3 ± 0.1
Daily Questionnaire (Cephalic) Week 40.4 ± 0.10.1 ± 0.030.2 ± 0.10.3 ± 0.1
Daily Questionnaire (Cephalic) Week 50.2 ± 0.10.2 ± 0.10.2 ± 0.10.2 ± 0.1
Daily Questionnaire (Cephalic) Week 60.2 ± 0.10.3 ± 0.10.2 ± 0.10.2 ± 0.1
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

Time frame:
Weekly for 6 weeks
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (Epidermal) Week 10.1 ± 0.020.1 ± 0.10.01 ± 0.010.03 ± 0.01
Daily Questionnaire (Epidermal) Week 20.1 ± 0.040.02 ± 0.010.04 ± 0.020.04 ± 0.02
Daily Questionnaire (Epidermal) Week 30.04 ± 0.030.1 ± 0.10.1 ± 0.040.05 ± 0.03
Daily Questionnaire (Epidermal) Week 40.1 ± 0.040.02 ± 0.010.1 ± 0.10.04 ± 0.02
Daily Questionnaire (Epidermal) Week 50.1 ± 0.040.02 ± 0.010.02 ± 0.020.02 ± 0.02
Daily Questionnaire (Epidermal) Week 60.1 ± 0.040.02 ± 0.020.01 ± 0.010.02 ± 0.02
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

Time frame:
Weekly for 6 weeks
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (ENT) Week 10.2 ± 0.10.1 ± 0.40.1 ± 0.040.1 ± 0.04
Daily Questionnaire (ENT) Week 20.3 ± 0.20.4 ± 0.10.1 ± 0.030.1 ± 0.04
Daily Questionnaire (ENT) Week 30.3 ± 0.10.2 ± 0.10.2 ± 0.10.2 ± 0.1
Daily Questionnaire (ENT) Week 40.4 ± 0.20.2 ± 0.10.2 ± 0.10.2 ± 0.1
Daily Questionnaire (ENT) Week 50.3 ± 0.10.2 ± 0.10.2 ± 0.10.2 ± 0.1
Daily Questionnaire (ENT) Week 60.2 ± 0.10.2 ± 0.10.2 ± 0.10.1 ± 0.1
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

Time frame:
Weekly for 6 weeks
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (Behavioral) Week 10.5 ± 0.10.2 ± 0.10.2 ± 0.10.5 ± 0.1
Daily Questionnaire (Behavioral) Week 20.4 ± 0.10.2 ± 0.10.1 ± 0.10.6 ± 0.2
Daily Questionnaire (Behavioral) Week 30.4 ± 0.20.1 ± 0.10.1 ± 0.10.5 ± 0.1
Daily Questionnaire (Behavioral) Week 40.4 ± 0.20.1 ± 0.10.2 ± 0.010.5 ± 0.1
Daily Questionnaire (Behavioral) Week 50.6 ± 0.20.2 ± 0.10.1 ± 0.10.5 ± 0.2
Daily Questionnaire (Behavioral) Week 60.4 ± 0.10.3 ± 0.20.2 ± 0.10.5 ± 0.2
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

Time frame:
Weekly for 6 weeks
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (Emetic) Week 10.05 ± 0.040.003 ± 0.0030.1 ± 0.10.1 ± 0.2
Daily Questionnaire (Emetic) Week 20.1 ± 0.10.1 ± 0.040.1 ± 0.040.03 ± 0.01
Daily Questionnaire (Emetic) Week 30.1 ± 0.040.1 ± 0.10.1 ± 0.10.1 ± 0.1
Daily Questionnaire (Emetic) Week 40.1 ± 0.10.02 ± 0.020.1 ± 0.10.1 ± 0.04
Daily Questionnaire (Emetic) Week 50.1 ± 0.10.1 ± 0.030.1 ± 0.10.03 ± 0.02
Daily Questionnaire (Emetic) Week 60.1 ± 0.10.1 ± 0.10.1 ± 0.10.08 ± 0.04
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

Time frame:
Weekly for 6 weeks
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (Constipation) Week 10.2 ± 0.10.1 ± 0.10.4 ± 0.20.4 ± 0.2
Daily Questionnaire (Constipation) Week 20.1 ± 0.040.2 ± 0.10.3 ± 0.10.7 ± 0.3
Daily Questionnaire (Constipation) Week 30.3 ± 0.10.2 ± 0.010.3 ± 0.10.6 ± 0.2
Daily Questionnaire (Constipation) Week 40.3 ± 0.10.1 ± 0.10.6 ± 0.20.7 ± 0.3
Daily Questionnaire (Constipation) Week 50.2 ± 0.10.1 ± 0.10.5 ± 0.10.7 ± 0.2
Daily Questionnaire (Constipation) Week 60.3 ± 0.10.1 ± 0.030.5 ± 0.20.5 ± 0.2
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

Time frame:
Weekly for 6 weeks
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (Diarrhea) Week 10.2 ± 0.10.1 ± 0.040.2 ± 0.10.2 ± 0.1
Daily Questionnaire (Diarrhea) Week 20.2 ± 0.10.2 ± 0.030.2 ± 0.10.1 ± 0.03
Daily Questionnaire (Diarrhea) Week 30.2 ± 0.10.1 ± 0.10.3 ± 0.10.3 ± 0.1
Daily Questionnaire (Diarrhea) Week 40.2 ± 0.10.1 ± 0.10.4 ± 0.10.3 ± 0.1
Daily Questionnaire (Diarrhea) Week 50.4 ± 0.10.2 ± 0.10.3 ± 0.10.1 ± 0.1
Daily Questionnaire (Diarrhea) Week 60.3 ± 0.10.1 ± 0.040.2 ± 0.10.2 ± 0.1
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

Time frame:
Weekly for 6 weeks
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (Fatigue) Week 11.1 ± 0.30.7 ± 0.20.7 ± 0.20.8 ± 0.2
Daily Questionnaire (Fatigue) Week 20.9 ± 0.30.6 ± 0.20.7 ± 0.20.9 ± 0.2
Daily Questionnaire (Fatigue) Week 30.9 ± 0.30.6 ± 0.20.7 ± 0.20.9 ± 0.2
Daily Questionnaire (Fatigue) Week 41.0 ± 0.30.4 ± 0.10.6 ± 0.20.9 ± 0.3
Daily Questionnaire (Fatigue) Week 50.8 ± 0.30.5 ± 0.10.6 ± 0.20.8 ± 0.2
Daily Questionnaire (Fatigue) Week 60.6 ± 0.30.5 ± 0.20.5 ± 0.20.7 ± 0.2
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

Time frame:
Weekly for 6 weeks
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (Satiety) Week 10.8 ± 0.20.7 ± 0.20.9 ± 0.20.9 ± 0.2
Daily Questionnaire (Satiety) Week 20.7 ± 0.20.3 ± 0.10.8 ± 0.21.1 ± 0.3
Daily Questionnaire (Satiety) Week 30.9 ± 0.30.3 ± 0.10.8 ± 0.20.9 ± 0.2
Daily Questionnaire (Satiety) Week 40.9 ± 0.30.3 ± 0.10.8 ± 0.21.0 ± 0.3
Daily Questionnaire (Satiety) Week 50.9 ± 0.30.4 ± 0.10.9 ± 0.30.9 ± 0.3
Daily Questionnaire (Satiety) Week 60.8 ± 0.30.3 ± 0.10.9 ± 0.30.8 ± 0.3
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).

Time frame:
Weekly for 6 weeks
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (Bowel Mov.) Week 11.55 ± 0.21.5 ± 0.21.3 ± 0.11.5 ± 0.1
Daily Questionnaire (Bowel Mov.) Weeks 2-51.4 ± 0.11.5 ± 0.11.5 ± 0.11.5 ± 0.1
Daily Questionnaire (Bowel Mov.) Week 61.5 ± 0.21.4 ± 0.11.4 ± 0.11.6 ± 0.2
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep

Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire.

Time frame:
Weekly for 6 weeks
Reported as:
Mean · Hours
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep
HoursPlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Daily Questionnaire (Hours of Sleep) Week 16.8 ± 0.26.6 ± 0.27.1 ± 0.16.6 ± 0.2
Daily Questionnaire (Hours of Sleep) Week 26.7 ± 0.16.8 ± 0.27.1 ± 0.26.9 ± 0.2
Daily Questionnaire (Hours of Sleep) Week 36.5 ± 0.26.8 ± 0.27.1 ± 0.26.7 ± 0.2
Daily Questionnaire (Hours of Sleep) Week 46.6 ± 0.27.0 ± 0.27.3 ± 0.26.8 ± 0.2
Daily Questionnaire (Hours of Sleep) Week 56.8 ± 0.27.0 ± 0.26.9 ± 0.26.9 ± 0.2
Daily Questionnaire (Hours of Sleep) Week 66.8 ± 0.27.0 ± 0.27.1 ± 0.16.7 ± 0.2
PrimaryEvaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires

Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort).

Time frame:
Weeks 1, 5, and 6
Reported as:
Mean · units on a scale
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
units on a scalePlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
GSRS (Abdominal Pain) Week 11.6 ± 0.11.3 ± 0.11.4 ± 0.11.5 ± 0.2
GSRS (Abdominal Pain) Week 51.8 ± 0.11.5 ± 0.11.6 ± 0.11.6 ± 0.1
GSRS (Abdominal Pain) Week 61.7 ± 0.11.6 ± 0.21.6 ± 0.11.3 ± 0.1
GSRS (Reflux) Week 11.3 ± 0.11.3 ± 0.21.1 ± 0.11.1 ± 0.1
GSRS (Reflux) Week 51.3 ± 0.11.3 ± 0.21.1 ± 0.11.2 ± 0.1
GSRS (Reflux) Week 61.3 ± 0.11.3 ± 0.21.1 ± 0.11.2 ± 0.1
GSRS (Indigestion) Week 11.8 ± 0.11.4 ± 0.11.5 ± 0.011.7 ± 0.1
GSRS (Indigestion) Week 51.9 ± 0.21.6 ± 0.11.9 ± 0.11.6 ± 0.1
GSRS (Indigestion) Week 61.9 ± 0.11.3 ± 0.11.6 ± 0.11.7 ± 0.1
GSRS (Constipation) Week 11.5 ± 0.11.1 ± 0.11.4 ± 0.11.4 ± 0.1
GSRS (Constipation) Week 51.6 ± 0.11.2 ± 0.11.6 ± 0.21.8 ± 0.2
GSRS (Constipation) Week 61.5 ± 0.11.2 ± 0.11.6 ± 0.21.7 ± 0.2
GSRS (Diarrhea) Week 11.3 ± 0.11.2 ± 0.11.3 ± 0.21.4 ± 0.1
GSRS (Diarrhea) Week 51.7 ± 0.21.2 ± 0.11.6 ± 0.21.5 ± 0.1
GSRS (Diarrhea) Week 61.8 ± 0.21.3 ± 0.11.4 ± 0.21.3 ± 0.1

Adverse events

Collected over Data monitoring adverse events was collected over the study period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/20 (0%)0/20 (0%)
B. Subtilis R0179 (0.1 Billion CFU)—1/21 (4.8%)1/21 (4.8%)
B. Subtilis R0179 (1 Billion CFU)—0/22 (0%)0/22 (0%)
B. Subtilis R0179 (10 Billion CFU)—0/20 (0%)1/20 (5%)
Most frequent serious events
Most frequent serious events
EventPlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
HypotensionBlood and lymphatic system disorders0/201/210/220/20
Most frequent other events
Most frequent other events
EventPlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)
Itchiness and Redness SymptomsSkin and subcutaneous tissue disorders0/200/210/221/20
Diarrheal SymptomsGastrointestinal disorders0/201/210/220/20

Baseline characteristics

Participants who completed all study requirements were included in the baseline analysis population. 2 participants in the 1 Billion CFU group were excluded from the baseline analysis because they did not complete all study requirements.

Age, Categorical
Age, Categorical(Participants)PlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)Total
<=18 years00000
Between 18 and 65 years2021202081
>=65 years00000
Age, Continuous
Age, Continuous(years)PlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)Total
Median23 (20 to 46)23 (20 to 49)22 (20 to 31)23 (19 to 46)23 (19 to 49)
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)Total
Female111381042
Male98121039
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)PlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)Total
Asian272213
Black422210
Hispanic323210
White99131445
Other21003
Region of Enrollment
Region of Enrollment(participants)PlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)Total
United States2021202081
BMI Percentiles
BMI Percentiles(participants)PlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)Total
<85th % (Healthy Weight)101213944
85th-94th % (Overweight)674926
>= 95th % (Obese)423211
Activity Level
Activity Level(mins of moderate and intense activity)PlaceboB. Subtilis R0179 (0.1 Billion CFU)B. Subtilis R0179 (1 Billion CFU)B. Subtilis R0179 (10 Billion CFU)Total
Mean185.5 ± 70.9197.3 ± 84.5168.3 ± 74.9199.0 ± 57.9185.9 ± 72.4
08

Study locations

1 site
  • University of Florida
    Gainesville, Florida 32611, United States
09

References and documents

Publications

  • Hong HA, Duc le H, Cutting SM. The use of bacterial spore formers as probiotics. FEMS Microbiol Rev. 2005 Sep;29(4):813-35. doi: 10.1016/j.femsre.2004.12.001. Epub 2004 Dec 16. PubMed 16102604 ↗
  • Oelschlaeger TA. Mechanisms of probiotic actions - A review. Int J Med Microbiol. 2010 Jan;300(1):57-62. doi: 10.1016/j.ijmm.2009.08.005. Epub 2009 Sep 23. PubMed 19783474 ↗
  • Sanders ME, Morelli L, Tompkins TA. Sporeformers as Human Probiotics: Bacillus, Sporolactobacillus, and Brevibacillus. Compr Rev Food Sci Food Saf. 2003 Jul;2(3):101-110. doi: 10.1111/j.1541-4337.2003.tb00017.x. PubMed 33451235 ↗
  • Tompkins TA, Hagen KE, Wallace TD, Fillion-Forte V. Safety evaluation of two bacterial strains used in Asian probiotic products. Can J Microbiol. 2008 May;54(5):391-400. doi: 10.1139/w08-022. PubMed 18449224 ↗
  • Tompkins TA, Xu X, Ahmarani J. A comprehensive review of post-market clinical studies performed in adults with an Asian probiotic formulation. Benef Microbes. 2010 Mar;1(1):93-106. doi: 10.3920/BM2008.1005. PubMed 21840798 ↗
  • Hanifi A, Culpepper T, Mai V, Anand A, Ford AL, Ukhanova M, Christman M, Tompkins TA, Dahl WJ. Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults. Benef Microbes. 2015 Mar;6(1):19-27. doi: 10.3920/BM2014.0031. PubMed 25062611 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2012, a primary completion of Oct 2012 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2015, 3 years 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2013
First posted
Mar 1, 2013
Start
Jul 2012
Primary completionActual
Oct 2012
CompletionActual
Oct 2012
Results first posted
Dec 17, 2015
Last update
Dec 17, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01802151
Lead sponsor
University of Florida
Collaborators
Lallemand Human Nutrition
Responsible party
Sponsor
First posted
Mar 1, 2013
Start date
Jul 2012
Primary completion
Oct 2012
Completion
Oct 2012
Results posted
Dec 17, 2015
Last update
Dec 17, 2015

Study contacts

Wendy J Dahl, PhD, RD
principal investigator · University of Florida
Bobbi Henken-Langkamp, PhD, RD
principal investigator · University of Florida
Volker Mai, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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