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Completed

NCT Number: NCT01802151

Evaluation of Bacillus Subtilis R0179 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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

B. subtilis R0179

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress

    Time frame: Weekly for 6 weeks

    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).

  2. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic

    Time frame: Weekly for 6 weeks

    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).

  3. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal

    Time frame: Weekly for 6 weeks

    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).

  4. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)

    Time frame: Weekly for 6 weeks

    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).

  5. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral

    Time frame: Weekly for 6 weeks

    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).

  6. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic

    Time frame: Weekly for 6 weeks

    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).

  7. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation

    Time frame: Weekly for 6 weeks

    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).

  8. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea

    Time frame: Weekly for 6 weeks

    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).

  9. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue

    Time frame: Weekly for 6 weeks

    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).

  10. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety

    Time frame: Weekly for 6 weeks

    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).

  11. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement

    Time frame: Weekly for 6 weeks

    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).

  12. Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep

    Time frame: Weekly for 6 weeks

    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.

  13. Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires

    Time frame: Weeks 1, 5, and 6

    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 outcomes

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

    Time frame: 6 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Lallemand Human Nutrition

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 1, 2013
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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