Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults

University of Florida

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: B. subtilis R0179; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01802151

177-2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

83 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.

Treatment:

Dietary Supplement: Placebo

B. subtilis R0179 (10 billion CFU)

Experimental group

Description:

B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks. * CFU (Colony Forming Unit)

Treatment:

Dietary Supplement: B. subtilis R0179

B. subtilis R0179 (1 billion CFU)

Experimental group

Description:

B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.

Treatment:

Dietary Supplement: B. subtilis R0179

B. subtilis R0179 (0.1 billion CFU)

Experimental group

Description:

B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.

Treatment:

Dietary Supplement: B. subtilis R0179