CClinicalTrials.gg
CompletedNCT03277157Updated Aug 28, 2019

B. Lactis B94 Effects of Gastrointestinal Function

An interventional study of B. lactis B94 and Placebo in Quality of Life, sponsored by University of Florida. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by University of Florida · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The aim of this study is to determine the effect of daily consumption of Bifidobacterium animalis ssp lactis B94 (B. lactis B94) on stool frequency, gastrointestinal (GI) transit time, and gastrointestinal symptoms in adults with Prader-Willi syndrome. Participants (18-75 years old, n=36) will be recruited and enrolled in a 20-week randomized, placebo-controlled, crossover study. Study participants will be randomized to B. lactis B94 or placebo each for a 4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Participants will complete daily questionnaires about stool frequency and stool form (transit). Dietary intake will also be assessed. A total of 5 stools (one in each period) will be collected for exploratory microbiota analysis. It is hypothesized that the B. lactis B94 will increase stool frequency, decrease the percentage of slow transit stools, and improve GI symptoms

Read the detailed description

Probiotics have been shown to improve symptoms of constipation by decreasing gastrointestinal transit time, increasing stool frequency, and normalizing stool form. A 20-week randomized, double-blinded, placebo-controlled crossover study will be carried out. Participants will complete a 4-week baseline period during which stool frequency, stool consistency (transit time), and gastrointestinal symptoms will be collected by paper questionnaire, and participants will collect a single stool. Dietary intake data (3-day) will be obtained during the baseline period. Participants will be randomized on or about day 29 and will consume Bifidobacterium animalis ssp lactis B94 (B. lactis B94) or placebo for 4 weeks, followed by a 4-week washout, 4 weeks on the alternative, and second 4-week washout. Participants will be randomized by sealed envelope method, prepared by a UF faculty member not affiliated with the study.

During the intervention and washout periods, participants will complete daily questionnaires to assess stool frequency and form (Bristol Stool Form Scale). Furthermore, they will complete Gastrointestinal Symptom Rating Scale (GSRS) at weeks 4, 8, 12, 16 and 20(± 3 days). During these same weeks (± 3 days) dietary intake data (28-day record) and stools will be collected (1 per period). Participants' height and weight will be taken at baseline, and weight during weeks 4, 8, 12, 16 and 20.

02

Conditions studied

  • Quality of Life
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Are willing and able to provide informed consent.
  • Have confirmed diagnosis of PWS
  • Are willing to have height and weight measured and provide demographic information (e.g. age, race, sex)
  • Are 18-75 years of age
  • Are willing to consume B. lactis B94 and placebo each for 4-week periods
  • Are willing to complete a daily questionnaire throughout the 20-week period.
  • Are willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) monthly throughout the 20-week study
  • Are willing to provide information about their dietary intake for 3-days every 4 weeks
  • Are willing to provide a valid social security for study payment purposes

Exclusion criteria

Exclusion Criteria:

  • Have a milk protein allergy
  • Are currently taking medications for diarrhea
  • Are currently taking probiotics supplements and do not want to discontinue prior to the start of the baseline period (i.e. those that discontinue will be included)
  • Have previously or are currently being treated for any gastrointestinal diseases such as (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Probiotic

    Bifidobacterium animalis ssp. lactis B94 at 15 billion CFUs per capsule

    Dietary Supplement: B. lactis B94

  • Placebo comparator
    Placebo

    Placebo veggie capsule.

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementB. lactis B94

    A probiotic dose of 15 billion per capsule.

    Also known as: Bifidobacterium animalis ssp lactis B94

  • Dietary supplementPlacebo

    Placebo capsule

    Also known as: Placebo capsule

05

What researchers measure

Primary outcomes

  1. Stool frequency

    Weekly stool frequency - difference between treatments

    Time frame: 4 weeks

Secondary outcomes

  1. Stool frequency percentage change

    Weekly stool frequency: percentage change from baseline

    Time frame: 4 weeks

  2. Bristol Stool Form

    Percentage slow transit (Bristol Stool Form Scale 1 and 2)

    Time frame: 4 weeks

  3. Gastrointestinal symptoms

    Decrease in syndromes of Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: 4 weeks

  4. Compliance

    \>80% of supplement intake

    Time frame: 4 weeks

06

Study locations

3 sites
  • ARC of Alachua County
    Gainesville, Florida 32606, United States
  • UF Health Pediatrics - Gerold L. Schiebler CMS Center
    Gainesville, Florida 32608, United States
  • Food Science and Human Nutrition Department, University of Florida
    Gainesville, Florida 32611, United States
07

References and documents

Publications

  • Alyousif Z, Miller JL, Sandoval MY, MacPherson CW, Nagulesapillai V, Dahl WJ. The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader-Willi syndrome: study protocol for a randomized controlled trial. Trials. 2018 Apr 27;19(1):256. doi: 10.1186/s13063-018-2648-x. PubMed 29703235 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03277157
Lead sponsor
University of Florida
Collaborators
Lallemand Health Solutions
Responsible party
Sponsor
First posted
Sep 8, 2017
Start date
Dec 8, 2017
Primary completion
Oct 31, 2018
Completion
Jul 17, 2019
Last update
Aug 28, 2019

Study contacts

Wendy J Dahl, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion