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Probiotic Detection and Persistence Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065503
Recruitment Status : Active, not recruiting
First Posted : August 22, 2019
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
Lallemand Health Solutions, Inc.
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Biological: Probiotic Strains Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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.
Actual Study Start Date : December 6, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

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.
Biological: Probiotic 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.




Primary Outcome Measures :
  1. 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.

  2. 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 ]
    using strain-specific qPCR assays.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065503


Locations
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United States, Florida
Food Science and Human Nutrition Department
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Lallemand Health Solutions, Inc.
Investigators
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Principal Investigator: Wendy Dahl University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04065503    
Other Study ID Numbers: IRB201902202
OCR26142 ( Other Identifier: UF OnCore )
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
probiotic
gut transit time