Evaluation of Jarro-Dophilus EPS® Probiotic Formulations

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Jarro-Dophilus EPS® (5 billion CFU/capsule)
* Dietary Supplement: Jarro-Dophilus EPS® High Potency (25 billion CFU/capsule)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jarro-Dophilus EPS® Group<br>Jarro-Dophilus EPS® (5 billion CFU/capsule) probiotic formulation capsule for 28 days | Dietary Supplement: Jarro-Dophilus EPS® (5 billion CFU/capsule)<br>* 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.<br>|
| Experimental: Jarro-Dophilus EPS® High Potency Group<br>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)<br>* 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.<br>|
| Placebo Comparator: Placebo Group<br>Placebo capsule for 28 days | Dietary Supplement: Placebo<br>* One capsule (containing potato starch, magnesium stearate and ascorbic acid) will be taken once a day for a period of 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota Studies (Composition) | 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) | 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) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jarro-Dophilus, probiotic, microbiota, gastrointestinal