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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • Food Science and Human Nutrition Department

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Day 1; Day 2; Day 3, Day 4, Day 7, Day 10
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.
Day 14, Day 15, Day 16, Day 17, Day 18, Day 21, Day 24, Day 28, Day 35, Day 42

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lallemand Health Solutions, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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