- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065503
Probiotic Detection and Persistence Study
January 14, 2021 updated by: University of Florida
Detection and Persistence of a Product Containing L. Helveticus R-0052, L. Casei HA-108, B. Breve HA-129, B. Longum R-0175 and S. Thermophilus HA-110 in Healthy Adults: an Open-label Pilot Study.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Food Science and Human Nutrition Department
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Adults
Healthy adults will be given probiotic strains to evaluate the detection and persistence of the strains in the participant's feces.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in time to detection of probiotic strains
Time Frame: Day 1; Day 2; Day 3, Day 4, Day 7, Day 10
|
using strain-specific qPCR assays.
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Day 1; Day 2; Day 3, Day 4, Day 7, Day 10
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Change in time to non-detection (persistence) of probiotic strains
Time Frame: Day 14, Day 15, Day 16, Day 17, Day 18, Day 21, Day 24, Day 28, Day 35, Day 42
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using strain-specific qPCR assays.
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Day 14, Day 15, Day 16, Day 17, Day 18, Day 21, Day 24, Day 28, Day 35, Day 42
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole gut transit time
Time Frame: Day 1, Day 2, Day 3, Day 4
|
Whole gut transit time measured by radiopaque marker recovery in intervention stools
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Day 1, Day 2, Day 3, Day 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wendy Dahl, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2019
Primary Completion (Actual)
February 26, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
August 20, 2019
First Submitted That Met QC Criteria
August 21, 2019
First Posted (Actual)
August 22, 2019
Study Record Updates
Last Update Posted (Actual)
January 19, 2021
Last Update Submitted That Met QC Criteria
January 14, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB201902202
- OCR26142 (Other Identifier: UF OnCore)
- AGR00015606 (Other Identifier: UFIRST)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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