NCT01802151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

December 17, 2015

Completed
Last Updated

December 17, 2015

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

February 20, 2013

Results QC Date

March 30, 2015

Last Update Submit

November 13, 2015

Conditions

Healthy

Keywords

probioticsmicrobiotasurvivalgastrointestinalwellness

Outcome Measures

Primary Outcomes (13)

  • 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 Outcomes (1)

  • Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)

    6 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

B. subtilis R0179 (10 billion CFU)

EXPERIMENTAL

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 (1 billion CFU)

EXPERIMENTAL

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

Dietary Supplement: B. subtilis R0179

B. subtilis R0179 (0.1 billion CFU)

EXPERIMENTAL

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

Dietary Supplement: B. subtilis R0179

Interventions

B. subtilis R0179DIETARY_SUPPLEMENT

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

B. subtilis R0179 (0.1 billion CFU)B. subtilis R0179 (1 billion CFU)B. subtilis R0179 (10 billion CFU)
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (6)

  • 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.

    PMID: 16102604BACKGROUND

  • 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.

    PMID: 19783474BACKGROUND

  • 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.

    PMID: 33451235BACKGROUND

  • 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.

    PMID: 18449224BACKGROUND

  • 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.

    PMID: 21840798BACKGROUND

  • 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.

    PMID: 25062611DERIVED

Related Links

Results Point of Contact

Title
Dr. Wendy Dahl
Organization
Department of Food Science and Human Nutrition, University of Florida
wdahl@ufl.edu
352-392-1991

Study Officials

  • Wendy J Dahl, PhD, RD

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Bobbi Henken-Langkamp, PhD, RD

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Volker Mai, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2013

First Posted

March 1, 2013

Study Start

July 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 17, 2015

Results First Posted

December 17, 2015

Record last verified: 2015-11

Locations

US(1)