Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of three doses of the probiotic B. subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general wellness in healthy young adults, survival through the gastrointestinal tract and impact on intestinal microbes.

Detailed Description
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A 6 week randomized, double blind placebo controlled trial in healthy young adults aged 18 to 50. Participants will be administered an oral dose of B. subtilis or placebo (1 capsule/day) for a period of 4 weeks. Viable counts will be measured from stool samples to assess transit survival, daily questionnaires (DQ) will be administered to assess general wellness, and gastrointestinal (GI) symptoms will be evaluated three times with the Gastrointestinal Symptom Response Scale (GSRS) questionnaire.

Official Title
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Evaluation of Bacillus Subtilis R0179 in Capsules on Gastrointestinal Survival, Transit Time, Gastrointestinal Symptoms, and General Wellness in Healthy Young Adults

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: B. subtilis R0179
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants Are 18-50 years of age Are willing and able to complete the Informed Consent Form in English Are willing to complete the GPAQ (Global Physical Activity Questionnaire) at baseline and during the last week of the study as well as completing the GSRS (Gastrointestinal Symptom Response Survey) questionnaire at baseline, during treatment and post treatment Are currently moderately active as determined by the GPAQ (Global Physical Activity Questionnaire) Are willing to have height and weight measured and to provide demographic information (age, race, sex) Are willing to consume B. subtilis R0179 (approximate doses of 1, 10, or 0.1 billion CFU per day) or placebo for a 28 day period by capsule (1 per day) Are willing to complete daily questionnaires regarding general and gastrointestinal wellness for the duration of the study Are willing to provide 1 stool at baseline, 1 stool during week 4 of the treatment and 1 stool after 7 days of washout Are willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide social security number, but no financial reimbursement can be provided Are willing to have internet access for the duration of the study Exclusion Criteria: Potential Participants will be excluded if they Do not meet the inclusion criteria Are currently taking medications for constipation or diarrhea Have taken antibiotics within the past four weeks prior to randomization Are currently taking probiotics supplements and do not want to discontinue a minimum of two weeks prior to the study Known to have or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), other chronic diseases (diabetes, kidney disease, etc.) or immune-compromising diseases or conditions (HIV, AIDS, autoimmune, hepatitis, cancer, transplant patient etc.)

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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Accepts Healthy Volunteers

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks. | Dietary Supplement: Placebo<br>* Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.<br>|
| Experimental: B. subtilis R0179 (10 billion CFU)<br>B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks. * CFU (Colony Forming Unit) | Dietary Supplement: B. subtilis R0179<br>* B. subtilis R0179 for a period of 4 weeks. One capsule per day.<br>|
| Experimental: B. subtilis R0179 (1 billion CFU)<br>B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks. | Dietary Supplement: B. subtilis R0179<br>* B. subtilis R0179 for a period of 4 weeks. One capsule per day.<br>|
| Experimental: B. subtilis R0179 (0.1 billion CFU)<br>B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks. | Dietary Supplement: B. subtilis R0179<br>* B. subtilis R0179 for a period of 4 weeks. One capsule per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms). | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep | Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire. | Weekly for 6 weeks | 
| Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires | Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort). | Weeks 1, 5, and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) | Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g). | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, microbiota, survival, gastrointestinal, wellness