Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults
NCT ID: NCT01802151
Last Updated: 2015-12-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
83 participants
INTERVENTIONAL
2012-07-31
2012-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo
Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
B. subtilis R0179 (10 billion CFU)
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
\* CFU (Colony Forming Unit)
B. subtilis R0179
B. subtilis R0179 for a period of 4 weeks. One capsule per day.
B. subtilis R0179 (1 billion CFU)
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179
B. subtilis R0179 for a period of 4 weeks. One capsule per day.
B. subtilis R0179 (0.1 billion CFU)
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179
B. subtilis R0179 for a period of 4 weeks. One capsule per day.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
B. subtilis R0179
B. subtilis R0179 for a period of 4 weeks. One capsule per day.
Placebo
Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.)
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lallemand Human Nutrition
UNKNOWN
University of Florida
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wendy J Dahl, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Bobbi Henken-Langkamp, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Volker Mai, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Florida
Gainesville, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
177-2012
Identifier Type: -
Identifier Source: org_study_id