Clinical trial NCT01802151: Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults
Official title: Evaluation of Bacillus Subtilis R0179 in Capsules on Gastrointestinal Survival, Transit Time, Gastrointestinal Symptoms, and General Wellness in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: probiotics
microbiota
survival
gastrointestinal
wellness
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Lallemand Human Nutrition
First posted: 2013-03-01
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.)

Primary outcomes:
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep
timeFrame: Weekly for 6 weeks
measure: Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
timeFrame: Weeks 1, 5, and 6
Secondary outcomes:
measure: Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Wendy J Dahl, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Bobbi Henken-Langkamp, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Volker Mai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Oelschlaeger TA. Mechanisms of probiotic actions - A review. Int J Med Microbiol. 2010 Jan;300(1):57-62. doi: 10.1016/j.ijmm.2009.08.005. Epub 2009 Sep 23.
citation: Sanders ME, Morelli L, Tompkins TA. Sporeformers as Human Probiotics: Bacillus, Sporolactobacillus, and Brevibacillus. Compr Rev Food Sci Food Saf. 2003 Jul;2(3):101-110. doi: 10.1111/j.1541-4337.2003.tb00017.x.
citation: Tompkins TA, Hagen KE, Wallace TD, Fillion-Forte V. Safety evaluation of two bacterial strains used in Asian probiotic products. Can J Microbiol. 2008 May;54(5):391-400. doi: 10.1139/w08-022.
citation: Tompkins TA, Xu X, Ahmarani J. A comprehensive review of post-market clinical studies performed in adults with an Asian probiotic formulation. Benef Microbes. 2010 Mar;1(1):93-106. doi: 10.3920/BM2008.1005.
citation: Hanifi A, Culpepper T, Mai V, Anand A, Ford AL, Ukhanova M, Christman M, Tompkins TA, Dahl WJ. Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults. Benef Microbes. 2015 Mar;6(1):19-27. doi: 10.3920/BM2014.0031.