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Evaluation of Jarro-Dophilus EPS® Probiotic Formulations

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ClinicalTrials.gov Identifier: NCT02693314
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Jarro-Dophilus EPS® (5 billion CFU/capsule) Dietary Supplement: Jarro-Dophilus EPS® High Potency (25 billion CFU/capsule) Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : March 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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.




Primary Outcome Measures :
  1. Microbiota Studies (Composition) [ Time Frame: Changes from Baseline, Week 4 of Treatment and Week 5 ]
    Changes in fecal lactobacilli and bifidobacteria between treatment groups.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02693314


Locations
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United States, Florida
Food Science and Human Nutrition Department, University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Lallemand Health Solutions
Investigators
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Principal Investigator: Wendy J Dahl, PhD, RD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02693314     History of Changes
Other Study ID Numbers: IRB201401031
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Jarro-Dophilus
probiotic
microbiota
gastrointestinal