Status:
COMPLETED
Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Hong Kong Association for Health Care
Integrated Chinese Medicine Holdings
Conditions:
Human Gut Microbiota
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
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 he...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01414010
Start Date
August 1 2011
End Date
February 1 2012
Last Update
July 24 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215