- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01414010
Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota
June 25, 2017 updated by: Ciaran Kelly, Beth Israel Deaconess Medical Center
Effects of Mushroom Extract, S Boulardii and Amoxicillin on the Human Microbiome
The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut microbiota of healthy volunteers.
It is expected that treatment will result in the rapid and reproducible alterations in fecal microbiota that will spontaneously reverse in the weeks after treatment is discontinued.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 to 39 years (male or female)
- Good general health
- Able to comply with study requirements and to provide informed consent
- For women of childbearing potential
- A negative urine pregnancy test immediately prior to starting the study treatment
- Agreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up)
Exclusion Criteria:
- Any diagnosed autoimmune disease
- History of organ transplantation
- Known chronic or recurrent systemic disorder associated with immunocompromise
- A history of allergy or hypersensitivity to mushroom or mushroom extract, brewer's or baker's yeast or to penicillins or cephalosporins (including amoxicillin).
- History of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness).
- Systemic antibacterial therapy during the 3 months prior to study enrollment
- New prescription medications during the 4 weeks prior to study enrollment
- Prescription or OTC medications or supplements that are known to alter gut function or microflora (i.e. acid antisecretory drugs, probiotics) during the 4 weeks prior to study enrollment
- Active gastrointestinal or metabolic disease
- Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy)
- History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily
- Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Probiotic
|
250 mg, 3 times daily on an empty stomach for 14 days
|
Active Comparator: Prebiotic
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1,200 mg, 3 times daily on an empty stomach for 14 days
Other Names:
|
Active Comparator: Antibiotic
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250 mg 3 times daily at least 1 hour before meals for 7 days
|
No Intervention: Control
Control group, no intervention given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bacteria Prevalence in Stool
Time Frame: Day 0 to 56
|
The most prevalent bacterial genera within the study population Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56 |
Day 0 to 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ciaran P Kelly, MD, Beth Israel Deaconess Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
August 5, 2011
First Submitted That Met QC Criteria
August 10, 2011
First Posted (Estimate)
August 11, 2011
Study Record Updates
Last Update Posted (Actual)
July 24, 2017
Last Update Submitted That Met QC Criteria
June 25, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010P000319
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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