Evaluation of Jarro-Dophilus EPS® Probiotic Formulations
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Mar 2016
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2016
CompletedFirst Posted
Study publicly available on registry
February 26, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMarch 23, 2018
March 1, 2018
1 month
February 17, 2016
March 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microbiota Studies (Composition)
Changes in fecal lactobacilli and bifidobacteria between treatment groups.
Changes from Baseline, Week 4 of Treatment and Week 5
Secondary Outcomes (5)
Digestive Health (Bowel Movement Frequency)
Changes from Baseline at Week 1,2,3,4 and Week 5
Digestive Health (Gastrointestinal Symptom Rating Scale)
Changes from Baseline at Week 1,2,3,4 and Week 5
Digestive Health (Gastrointestinal Function and General Wellness)
Changes from Baseline at Week 1,2,3,4 and Week 5
Microbiota Studies (Recovery)
Changes from Baseline, Week 4 of Treatment and Week 5
Microbiota Studies (Overall Composition)
Changes from Baseline, Week 4 of Treatment and Week 5
Study Arms (3)
Jarro-Dophilus EPS® Group
EXPERIMENTALJarro-Dophilus EPS® (5 billion CFU/capsule) probiotic formulation capsule for 28 days
Jarro-Dophilus EPS® High Potency Group
EXPERIMENTALJarro-Dophilus EPS® High Potency (25 billion CFU/capsule) probiotic formulation capsule for 28 days
Placebo Group
PLACEBO COMPARATORPlacebo capsule for 28 days
Interventions
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.
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.
One capsule (containing potato starch, magnesium stearate and ascorbic acid) will be taken once a day for a period of 28 days.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Lallemand Health Solutionscollaborator
Study Sites (1)
Food Science and Human Nutrition Department, University of Florida
Gainesville, Florida, 32611, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy J Dahl, PhD, RD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2016
First Posted
February 26, 2016
Study Start
March 1, 2016
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
March 23, 2018
Record last verified: 2018-03