Probiotic Detection and Persistence Study

NCT04065503 | Completed Early Phase 1

• 3 other identifiers: IRB201902202OCR26142AGR00015606
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

probiotic; gut transit time

Outcome Measures

Primary Outcomes (2)

• Change in time to detection of probiotic strains

  using strain-specific qPCR assays.

  Day 1; Day 2; Day 3, Day 4, Day 7, Day 10

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

  using strain-specific qPCR assays.

  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

  Day 1, Day 2, Day 3, Day 4

Study Arms (1)

Healthy Adults

EXPERIMENTAL

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

Probiotic Strains BIOLOGICAL

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.

Healthy Adults

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Lallemand Health Solutions, Inc.: collaborator

Study Sites (1)

Food Science and Human Nutrition Department

Gainesville, Florida, 32611, United States

Location

Study Officials

• Wendy Dahl

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: December 6, 2019
• Primary Completion: February 26, 2020
• Study Completion: December 31, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)