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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

Tracking Information
First Submitted Date  ICMJE February 17, 2016
First Posted Date  ICMJE February 26, 2016
Last Update Posted Date March 23, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2016)
Microbiota Studies (Composition) [ Time Frame: Changes from Baseline, Week 4 of Treatment and Week 5 ]
Changes in fecal lactobacilli and bifidobacteria between treatment groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02693314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2016)
  • 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.
  • 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).
  • 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).
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Jarro-Dophilus EPS® Probiotic Formulations
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Jarro-Dophilus EPS® Group
    Jarro-Dophilus EPS® (5 billion CFU/capsule) probiotic formulation capsule for 28 days
    Intervention: Dietary Supplement: Jarro-Dophilus EPS® (5 billion CFU/capsule)
  • Experimental: Jarro-Dophilus EPS® High Potency Group
    Jarro-Dophilus EPS® High Potency (25 billion CFU/capsule) probiotic formulation capsule for 28 days
    Intervention: Dietary Supplement: Jarro-Dophilus EPS® High Potency (25 billion CFU/capsule)
  • Placebo Comparator: Placebo Group
    Placebo capsule for 28 days
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2016)
75
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2016)
60
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02693314
Other Study ID Numbers  ICMJE IRB201401031
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Lallemand Health Solutions
Investigators  ICMJE
Principal Investigator: Wendy J Dahl, PhD, RD University of Florida
PRS Account University of Florida
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP