Study Results
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View full resultsBasic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2011-08-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Prebiotic
Trametes versicolor extract
1,200 mg, 3 times daily on an empty stomach for 14 days
Probiotic
Saccharomyces boulardii
250 mg, 3 times daily on an empty stomach for 14 days
Antibiotic
Amoxicillin
250 mg 3 times daily at least 1 hour before meals for 7 days
Control
Control group, no intervention given.
No interventions assigned to this group
Interventions
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Trametes versicolor extract
1,200 mg, 3 times daily on an empty stomach for 14 days
Saccharomyces boulardii
250 mg, 3 times daily on an empty stomach for 14 days
Amoxicillin
250 mg 3 times daily at least 1 hour before meals for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
39 Years
ALL
Yes
Sponsors
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Hong Kong Association for Health Care
UNKNOWN
Integrated Chinese Medicine Holdings
UNKNOWN
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Ciaran Kelly
Professor of Medicine
Principal Investigators
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Ciaran P Kelly, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2010P000319
Identifier Type: -
Identifier Source: org_study_id
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