Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults

Not Applicable

Completed

Conditions: Healthy

Interventions: Dietary Supplement: Placebo
Dietary Supplement: B. subtilis R0179

Registration Number: NCT01802151

Lead Sponsor: University of Florida

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 83

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.)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
B. subtilis R0179 (1 billion CFU)	B. subtilis R0179	B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179 (10 billion CFU)	B. subtilis R0179	B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks. \* CFU (Colony Forming Unit)
B. subtilis R0179 (0.1 billion CFU)	B. subtilis R0179	B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress	Weekly for 6 weeks	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).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral	Weekly for 6 weeks	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).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal	Weekly for 6 weeks	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).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)	Weekly for 6 weeks	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).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep	Weekly for 6 weeks	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.
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires	Weeks 1, 5, and 6	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).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic	Weekly for 6 weeks	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).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation	Weekly for 6 weeks	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).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety	Weekly for 6 weeks	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).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic	Weekly for 6 weeks	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).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue	Weekly for 6 weeks	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).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea	Weekly for 6 weeks	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).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement	Weekly for 6 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)	6 weeks	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).