Evaluation of Jarro-Dophilus EPS® Probiotic Formulations
NCT ID: NCT02693314
Last Updated: 2018-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2016-03-31
2016-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Jarro-Dophilus EPS® Group
Jarro-Dophilus EPS® (5 billion CFU/capsule) probiotic formulation capsule for 28 days
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.
Jarro-Dophilus EPS® High Potency Group
Jarro-Dophilus EPS® High Potency (25 billion CFU/capsule) probiotic formulation capsule for 28 days
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 Group
Placebo capsule for 28 days
Placebo
One capsule (containing potato starch, magnesium stearate and ascorbic acid) will be taken once a day for a period of 28 days.
Interventions
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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.
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
One capsule (containing potato starch, magnesium stearate and ascorbic acid) will be taken once a day for a period of 28 days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Lallemand Health Solutions
INDUSTRY
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Wendy J Dahl, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Food Science and Human Nutrition Department, University of Florida
Gainesville, Florida, United States
Countries
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Other Identifiers
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IRB201401031
Identifier Type: -
Identifier Source: org_study_id
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