HealthyNCT01802151

Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults

A study testing B. subtilis R0179 in people with Healthy, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: B. subtilis R0179
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 83 participants
Where: 1 siteUnited States
Study dates: Jul 2012to Oct 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

Show all 16Show fewer

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.)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida
Gainesville, Florida, 32611

Other trials in United States

About this study

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

Read the 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.

Conditions: Healthy
Being tested: B. subtilis R0179, Placebo
Keywords: probiotics, microbiota, survival, gastrointestinal, wellness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

B. subtilis R0179Dietary supplement
1. 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.

Study groups in NCT01802151
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks. Receives: 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) Receives: 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. Receives: 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. Receives: Dietary Supplement: B. subtilis R0179

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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)
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).
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Oct 2012

First posted1 Mar 2013 (estimated)
Study startJul 2012
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01802151
Sponsor's protocol ID: 177-2012
Status last verified: Nov 2015
First submitted: 20 Feb 2013
Last updated: 17 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 16102604
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.
PubMed 19783474
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.
PubMed 33451235
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.
PubMed 18449224
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.
PubMed 21840798
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.
PubMed 25062611

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Bacillus Subtilis R0179 in Capsules on Gastrointestinal Survival, Transit Time, Gastrointestinal Symptoms, and General Wellness in Healthy Young Adults
ClinicalTrials.gov ID: NCT01802151
Acronym / sponsor ID: 177-2012
Conditions: Healthy
Keywords: probiotics, microbiota, survival, gastrointestinal, wellness
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: Lallemand Human Nutrition
Study start: Jul 2012
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 1 Mar 2013 (estimated)
Results: Posted 17 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Dietary Supplement: PlaceboPlacebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
B. subtilis R0179 (10 billion CFU)	Experimental	Dietary Supplement: B. subtilis R0179B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks. * CFU (Colony Forming Unit)
B. subtilis R0179 (1 billion CFU)	Experimental	Dietary Supplement: B. subtilis R0179B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179 (0.1 billion CFU)	Experimental	Dietary Supplement: B. subtilis R0179B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (16 listed)

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)

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
B. subtilis R0179B. subtilis R0179 for a period of 4 weeks. One capsule per day.	Dietary supplement	B. subtilis R0179 (0.1 billion CFU), B. subtilis R0179 (1 billion CFU), B. subtilis R0179 (10 billion CFU)
PlaceboPlacebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.	Dietary supplement	Placebo

Primary outcome

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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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).

1 secondary outcome

Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)
Time frame: 6 weeks

Results and safety

Results posted to the registry on 17 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	20	20
B. Subtilis R0179 (0.1 Billion CFU)	21	21
B. Subtilis R0179 (1 Billion CFU)	22	20
B. Subtilis R0179 (10 Billion CFU)	20	20

Primary outcome: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress

Time frame: Weekly for 6 weeks. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 20	B. Subtilis R0179 (0.1 Billion CFU) n = 21	B. Subtilis R0179 (1 Billion CFU) n = 20	B. Subtilis R0179 (10 Billion CFU) n = 20
Daily Questionnaire (GI Distress) Week 1	0.5 (0.8)	0.3 (0.1)	0.6 (0.1)	0.7 (0.1)
Daily Questionnaire (GI Distress) Week 2	0.5 (0.1)	0.4 (0.1)	0.6 (0.1)	0.5 (0.1)
Daily Questionnaire (GI Distress) Week 3	0.6 (0.1)	0.3 (0.1)	0.6 (0.1)	0.6 (0.1)
Daily Questionnaire (GI Distress) Week 4	0.6 (0.1)	0.3 (0.01)	0.7 (0.1)	0.7 (0.1)
Daily Questionnaire (GI Distress) Week 5	0.6 (0.1)	0.3 (0.1)	0.7 (0.1)	0.5 (0.1)
Daily Questionnaire (GI Distress) Week 6	0.5 (0.1)	0.3 (0.1)	0.6 (0.1)	0.4 (0.1)

Population analysed: Participants who completed all study requirements were included in the baseline analysis population.

Primary outcome: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic

Time frame: Weekly for 6 weeks. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 20	B. Subtilis R0179 (0.1 Billion CFU) n = 21	B. Subtilis R0179 (1 Billion CFU) n = 20	B. Subtilis R0179 (10 Billion CFU) n = 20
Daily Questionnaire (Cephalic) Week 1	0.2 (0.1)	0.2 (0.1)	0.2 (0.04)	0.2 (0.1)
Daily Questionnaire (Cephalic) Week 2	0.2 (0.1)	0.2 (0.1)	0.1 (0.04)	0.2 (0.1)
Daily Questionnaire (Cephalic) Week 3	0.2 (0.1)	0.2 (0.1)	0.1 (0.04)	0.3 (0.1)
Daily Questionnaire (Cephalic) Week 4	0.4 (0.1)	0.1 (0.03)	0.2 (0.1)	0.3 (0.1)
Daily Questionnaire (Cephalic) Week 5	0.2 (0.1)	0.2 (0.1)	0.2 (0.1)	0.2 (0.1)
Daily Questionnaire (Cephalic) Week 6	0.2 (0.1)	0.3 (0.1)	0.2 (0.1)	0.2 (0.1)

Population analysed: Participants who completed all study requirements were included in the baseline analysis population.

Primary outcome: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal

Time frame: Weekly for 6 weeks. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 20	B. Subtilis R0179 (0.1 Billion CFU) n = 21	B. Subtilis R0179 (1 Billion CFU) n = 20	B. Subtilis R0179 (10 Billion CFU) n = 20
Daily Questionnaire (Epidermal) Week 1	0.1 (0.02)	0.1 (0.1)	0.01 (0.01)	0.03 (0.01)
Daily Questionnaire (Epidermal) Week 2	0.1 (0.04)	0.02 (0.01)	0.04 (0.02)	0.04 (0.02)
Daily Questionnaire (Epidermal) Week 3	0.04 (0.03)	0.1 (0.1)	0.1 (0.04)	0.05 (0.03)
Daily Questionnaire (Epidermal) Week 4	0.1 (0.04)	0.02 (0.01)	0.1 (0.1)	0.04 (0.02)
Daily Questionnaire (Epidermal) Week 5	0.1 (0.04)	0.02 (0.01)	0.02 (0.02)	0.02 (0.02)
Daily Questionnaire (Epidermal) Week 6	0.1 (0.04)	0.02 (0.02)	0.01 (0.01)	0.02 (0.02)

Population analysed: Participants who completed all study requirements were included in the baseline analysis population.

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

Time frame: Weekly for 6 weeks. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 20	B. Subtilis R0179 (0.1 Billion CFU) n = 21	B. Subtilis R0179 (1 Billion CFU) n = 20	B. Subtilis R0179 (10 Billion CFU) n = 20
Daily Questionnaire (ENT) Week 1	0.2 (0.1)	0.1 (0.4)	0.1 (0.04)	0.1 (0.04)
Daily Questionnaire (ENT) Week 2	0.3 (0.2)	0.4 (0.1)	0.1 (0.03)	0.1 (0.04)
Daily Questionnaire (ENT) Week 3	0.3 (0.1)	0.2 (0.1)	0.2 (0.1)	0.2 (0.1)
Daily Questionnaire (ENT) Week 4	0.4 (0.2)	0.2 (0.1)	0.2 (0.1)	0.2 (0.1)
Daily Questionnaire (ENT) Week 5	0.3 (0.1)	0.2 (0.1)	0.2 (0.1)	0.2 (0.1)
Daily Questionnaire (ENT) Week 6	0.2 (0.1)	0.2 (0.1)	0.2 (0.1)	0.1 (0.1)

Population analysed: Participants who completed all study requirements were included in the baseline analysis population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Data monitoring adverse events was collected over the study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 20 (0%)	0 of 20 (0%)	Not reported
B. Subtilis R0179 (0.1 Billion CFU)	1 of 21 (4.8%)	1 of 21 (4.8%)	Not reported
B. Subtilis R0179 (1 Billion CFU)	0 of 22 (0%)	0 of 22 (0%)	Not reported
B. Subtilis R0179 (10 Billion CFU)	0 of 20 (0%)	1 of 20 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16102604Hong 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.
Background: PubMed 19783474Oelschlaeger 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.
Background: PubMed 33451235Sanders 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.
Background: PubMed 18449224Tompkins 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.
Background: PubMed 21840798Tompkins 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.
Derived from this study: PubMed 25062611Hanifi 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.
Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wendy J Dahl, PhD, RD principal investigator

University of Florida

Bobbi Henken-Langkamp, PhD, RD principal investigator

University of Florida

Volker Mai, PhD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing B. subtilis R0179 in people with Healthy, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress (time frame: Weekly for 6 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01802151, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.