NCT01802151 - Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults | Crick

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

83

Conditions

Healthy

Interventions

B. subtilis R0179DIETARY_SUPPLEMENT

B. subtilis R0179 for a period of 4 weeks. One capsule per day.

PlaceboDIETARY_SUPPLEMENT

Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.)

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes