N/A
N=83
Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01802151 ↗Enrolled (actual)
83
Serious AEs
1.2%
Results posted
Dec 2015
Primary outcome: Primary: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress — 0.5; 0.3; 0.6; 0.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- B. subtilis R0179 (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress |
0.5; 0.3; 0.6; 0.7; 0.5; 0.4 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic |
0.2; 0.2; 0.2; 0.2; 0.2; 0.2 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal |
0.1; 0.1; 0.01; 0.03; 0.1; 0.02 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) |
0.2; 0.1; 0.1; 0.1; 0.3; 0.4 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral |
0.5; 0.2; 0.2; 0.5; 0.4; 0.2 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic |
0.05; 0.003; 0.1; 0.1; 0.1; 0.1 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation |
0.2; 0.1; 0.4; 0.4; 0.1; 0.2 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea |
0.2; 0.1; 0.2; 0.2; 0.2; 0.2 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue |
1.1; 0.7; 0.7; 0.8; 0.9; 0.6 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety |
0.8; 0.7; 0.9; 0.9; 0.7; 0.3 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement |
1.55; 1.5; 1.3; 1.5; 1.4; 1.5 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep |
6.8; 6.6; 7.1; 6.6; 6.7; 6.8 | — |
| PRIMARY Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires |
1.6; 1.3; 1.4; 1.5; 1.8; 1.5 | — |
| SECONDARY Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) |
0.9; 0.9; 0.9; 1.2; 1.1; 4.6 | — |
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.
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT01802151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.