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Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults

This study has been completed.
Sponsor:
Collaborator:
Lallemand Human Nutrition
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01802151
First received: February 20, 2013
Last updated: November 13, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Healthy
Dietary Supplement: B. subtilis R0179
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Evaluation of Bacillus Subtilis R0179 in Capsules on Gastrointestinal Survival, Transit Time, Gastrointestinal Symptoms, and General Wellness in Healthy Young Adults

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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 the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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 the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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 the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT) [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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 the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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 the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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 the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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 the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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 the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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 the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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 the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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).

  • Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires [ Time Frame: Weeks 1, 5, and 6 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 83
Study Start Date: July 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802151

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Lallemand Human Nutrition
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01802151     History of Changes
Other Study ID Numbers: 177-2012 
Study First Received: February 20, 2013
Results First Received: March 30, 2015
Last Updated: November 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
probiotics
microbiota
survival
gastrointestinal
wellness

ClinicalTrials.gov processed this record on September 27, 2016