Evaluation of Jarro-Dophilus EPS® Probiotic Formulations

March 21, 2018 updated by: University of Florida

Evaluation of Jarro-Dophilus EPS® Probiotic Formulations on Probiotic Survival, Fecal Microbiota, Gastrointestinal Function and General Wellness in Healthy Adults: a Randomized, Double-blind, Dose-response Study

The purpose of this study is to determine the effects of the two doses of Jarro-Dophilus EPS® probiotic supplements on fecal lactobacillus and bifidobacteria numbers, transit survival of administered probiotic strains, fecal microbiota, gastrointestinal function and general wellbeing in healthy human adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be screened using the International Physical Activity Questionnaire (questions regarding physical activity, including intensity, duration and frequency) and inclusion/exclusion criteria. Participants will be scheduled to begin a 7-day baseline period, during which participants will complete daily questionnaires of bowel movement frequency, gastrointestinal symptoms and wellness. On or about day 8, height and weight will be determined. Participants will then be randomized to one of the following groups:

Group 1: Jarro-Dophilus EPS® (5 billion CFU/capsule), Group 2: Jarro-Dophilus EPS® Higher Potency (25 billion CFU/capsule), Group 3: Placebo capsule

Study participants will continue to complete the daily online questionnaire throughout the 28 days of treatment and for 7 days post treatment. Participants will also be asked to complete a weekly questionnaire on gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale) throughout the entire study. In addition, participants in each group will be asked to collect one stool sample at baseline, one stool sample during week 4 of treatment and an additional sample during the washout period. Stool samples will be analyzed and quantified for the probiotic bacteria and changes in the microbiota.

Participants will be asked to return any unconsumed supplements at the end of the treatment period. Additionally, the participants will be weighed after the treatment period and the washout period.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

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, University of Florida

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

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

To participate in the study you must

  • be between18-50 years of age
  • be willing to have your height and weight measured and provide demographic information
  • be willing to consume a probiotic or placebo capsule daily for 4 weeks
  • be willing to provide 3 stool samples during the study
  • be willing to complete a daily questionnaires regarding general and gastrointestinal wellness and the Gastrointestinal Symptom Rating Scale weekly throughout the entire 6-wk study
  • have daily access to a computer with Internet access for the entire 6-wk study
  • be willing and able to provide a valid social security for study payment purposes
  • be willing and able to provide a valid social security for study payment purposes
  • be willing to complete the International Physical Activity Questionnaire (asks you to report physical activity including intensity, duration and frequency)

Exclusion Criteria:

To participate in the study you must NOT

  • be currently taking medications for constipation or diarrhea
  • have previously or are you currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.), other chronic diseases (diabetes, kidney disease, etc.) or immune-compromising diseases or conditions (HIV, AIDS, autoimmune, hepatitis, cancer, transplant patient etc.)
  • have any known allergy to milk, milk protein, soy, gluten or have gluten sensitivity
  • have taken antibiotics within the past 4 weeks prior to randomization
  • be currently taking a probiotic supplement and are unwilling to discontinue it a minimum of 2 weeks prior to the study start
  • be a current smoker.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jarro-Dophilus EPS® Group
Jarro-Dophilus EPS® (5 billion CFU/capsule) probiotic formulation capsule for 28 days
Dietary supplement: Jarro-Dophilus EPS® (5 billion CFU/capsule)
One capsule containing 5 billion CFU of the probiotic mix (Lactobacillus helveticus, Lactobacillus rhamnosus, Lactobacillus casei, Pediococcus acidilactici, Bifidobacteria breve, Bifidobacteria longum, Lactobacillus plantarum and Lactobacillus lactis ssp. lactis) will be taken once a day for a period of 28 days.
Experimental: Jarro-Dophilus EPS® High Potency Group
Jarro-Dophilus EPS® High Potency (25 billion CFU/capsule) probiotic formulation capsule for 28 days
Dietary supplement: Jarro-Dophilus EPS® High Potency (25 billion CFU/capsule)
One capsule containing 25 billion CFU of the probiotic mix (Lactobacillus helveticus, Lactobacillus rhamnosus, Lactobacillus casei, Pediococcus acidilactici, Bifidobacteria breve, Bifidobacteria longum, Lactobacillus plantarum and Lactobacillus lactis ssp. lactis) will be taken once a day for a period of 28 days.
Placebo Comparator: Placebo Group
Placebo capsule for 28 days
Dietary supplement: Placebo
One capsule (containing potato starch, magnesium stearate and ascorbic acid) will be taken once a day for a period of 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiota Studies (Composition)
Time Frame: Changes from Baseline, Week 4 of Treatment and Week 5
Changes in fecal lactobacilli and bifidobacteria between treatment groups.
Changes from Baseline, Week 4 of Treatment and Week 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digestive Health (Bowel Movement Frequency)
Time Frame: Changes from Baseline at Week 1,2,3,4 and Week 5
Bowel movement frequency will be self-reported using a daily questionnaire.
Changes from Baseline at Week 1,2,3,4 and Week 5
Digestive Health (Gastrointestinal Symptom Rating Scale)
Time Frame: Changes from Baseline at Week 1,2,3,4 and Week 5
Measured by gastrointestinal symptoms (bloating, reflux, constipation, diarrhea) using the weekly Gastrointestinal Symptom Rating Scale (GSRS).
Changes from Baseline at Week 1,2,3,4 and Week 5
Digestive Health (Gastrointestinal Function and General Wellness)
Time Frame: Changes from Baseline at Week 1,2,3,4 and Week 5
Measured by gastrointestinal symptoms (gas, bloating, diarrhea, etc) assessed using a daily questionnaire. The daily questionnaire will also include questions regarding wellness and the Bristol Stool Scale (stool form and transit).
Changes from Baseline at Week 1,2,3,4 and Week 5
Microbiota Studies (Recovery)
Time Frame: Changes from Baseline, Week 4 of Treatment and Week 5
Change in the concentration and survival of the probiotic strains through intestinal passage using qPCR.
Changes from Baseline, Week 4 of Treatment and Week 5
Microbiota Studies (Overall Composition)
Time Frame: Changes from Baseline, Week 4 of Treatment and Week 5
Effects of the probiotic interventions on overall microbiota composition will be measured (e.g. 16S rRNA (ribosomal ribonucleic acid) sequencing).
Changes from Baseline, Week 4 of Treatment and Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Lallemand Health Solutions

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

March 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB201401031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Clinical Trials on Healthy

Clinical Trials on Jarro-Dophilus EPS® (5 billion CFU/capsule)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe