Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: B. subtilis R0179

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.	Dietary supplement: Placebo; Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
EXPERIMENTAL: B. subtilis R0179 (10 billion CFU); B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks. * CFU (Colony Forming Unit)	Dietary supplement: B. subtilis R0179; B. subtilis R0179 for a period of 4 weeks. One capsule per day.
EXPERIMENTAL: B. subtilis R0179 (1 billion CFU); B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.	Dietary supplement: B. subtilis R0179; B. subtilis R0179 for a period of 4 weeks. One capsule per day.
EXPERIMENTAL: B. subtilis R0179 (0.1 billion CFU); B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.	Dietary supplement: B. subtilis R0179; B. subtilis R0179 for a period of 4 weeks. One capsule per day.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Lallemand Human Nutrition
• Investigators: Principal Investigator: Bobbi Henken-Langkamp, PhD, RD, University of Florida

Publications and helpful links

General Publications

• Hong HA, Duc le H, Cutting SM. The use of bacterial spore formers as probiotics. FEMS Microbiol Rev. 2005 Sep;29(4):813-35. doi: 10.1016/j.femsre.2004.12.001. Epub 2004 Dec 16.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: February 20, 2013
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (ESTIMATE): March 1, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 17, 2015
• Last Update Submitted That Met QC Criteria: November 13, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: survival; probiotics; microbiota; wellness; gastrointestinal
• Other Study ID Numbers: 177-2012