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CompletedNCT04065503Updated Jan 19, 2021

Probiotic Detection and Persistence Study

An Early Phase 1 interventional study of Probiotic Strains in Healthy, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-19.

Sponsored by University of Florida · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The aims of this study are to determine how long it takes for the strains of a probiotic formulation to be detected in feces after the start of an intervention, how long they persist after the end of the intervention, and the associations between detection and persistence with total gut transit time.

Read the detailed description

This is a 10-week interventional, open-label pilot study designed to evaluate the detection and persistence of L. helveticus R-0052, L. casei NI319, B. breve NI337, and B. longum R-0175 strains in feces of healthy adults following the start and the end of IP intervention, respectively. This study will have an initial baseline period (4 weeks), a probiotic intervention (2 weeks) and a washout period (4 weeks). Participants will complete daily questionnaires regarding stool frequency, time of stool collections, and IP intake. A weekly Gastrointestinal Symptom Rating Scale (GSRS) questionnaire will be administered. Transit time will be assessed using radiopaque markers.

02

Conditions studied

  • Healthy

Keywords

  • probiotic
  • gut transit time
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.

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

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy adults ≥ 18 to \< 55 years of age.
  • Habitually produces at least one bowel movement per day.
  • Willingness to maintain their usual diet and exercise patterns throughout the study.
  • Able to provide written informed consent in English.
  • Willing to provide stools and complete questionnaires, records, and diaries associated with the study and to complete all study visits.
  • Willingness to discontinue consumption of probiotics and fermented products (e.g. yogurts, kombucha, fermented pickles and other fermented foods with live, active cultures) and probiotic supplements.

Exclusion criteria

Exclusion Criteria:

  • Elite athletes or long-distance runners.
  • Concurrent consumption of fermented foods or probiotics. However, individuals will be eligible for participation after a four (4) week wash-out period.
  • Known to be pregnant (self-disclosure) or breastfeeding or planning on becoming pregnant in the next 2 months.
  • Use of antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of the screening visit. The screened participant would be eligible to participate four (4) weeks after completing their course of antibiotics (washout period).
  • Use of other investigational products within 3 months of the screening visit.
  • Previously or are currently being treated for any previously or currently being treated for any intestinal disease or condition such as IBS, Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer.
  • Immune disorders or with possible immune deficient status (e.g. due to surgery).
  • Milk or soy allergy.
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Healthy Adults

    Healthy adults will be given probiotic strains to evaluate the detection and persistence of the strains in the participant's feces.

    Biological: Probiotic Strains

Interventions

  • BiologicalProbiotic Strains

    A commercial product containing L. helveticus R0052, L. casei HA-108, B. breve HA-129, and B. longum R0175 and S. thermophilus HA-110 be given to healthy adults across a 10-week open label pilot study.

06

What researchers measure

Primary outcomes

  1. Change in time to detection of probiotic strains

    using strain-specific qPCR assays.

    Time frame: Day 1; Day 2; Day 3, Day 4, Day 7, Day 10

  2. Change in time to non-detection (persistence) of probiotic strains

    using strain-specific qPCR assays.

    Time frame: Day 14, Day 15, Day 16, Day 17, Day 18, Day 21, Day 24, Day 28, Day 35, Day 42

Secondary outcomes

  1. Whole gut transit time

    Whole gut transit time measured by radiopaque marker recovery in intervention stools

    Time frame: Day 1, Day 2, Day 3, Day 4

07

Study locations

1 site
  • Food Science and Human Nutrition Department
    Gainesville, Florida 32611, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04065503
Collaborators
Lallemand Health Solutions
Responsible party
Sponsor
First posted
Aug 22, 2019
Start date
Dec 6, 2019
Primary completion
Feb 26, 2020
Completion
Dec 31, 2020
Last update
Jan 19, 2021

Study contacts

Wendy Dahl
principal investigator · University of Florida

Oversight

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 Jan 2021. You cannot join it, but the record below documents what was studied.

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