Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota
Information source: Beth Israel Deaconess Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Saccharomyces boulardii (Dietary Supplement); Amoxicillin Clavulanate (Drug); Saccharomyces boulardii AND Amoxicillin Clavulanate (Drug)
Sponsored by: Beth Israel Deaconess Medical Center
Official(s) and/or principal investigator(s):
Ciaran P Kelly, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center
The purpose of this study is to compare and contrast the effects of the probiotic
Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the
gut microbiota of healthy volunteers.
Official title: Open Label, Randomized Pilot Study to Examine The Effects of the Probiotic Saccharomyces Boulardii, the Antibiotic Amoxicillin/Clavulanate and the Combination on the Gut Microbiota of Healthy Volunteers
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Change in microbiome quantity
Change in microbiome diversity
Minimum age: 18 Years.
Maximum age: 65 Years.
- Age 18 to 65 years (male or female)
- Good general health
- Able to comply with study requirements and to provide informed consent
- For women of childbearing potential oA negative urine pregnancy test immediately
prior to starting the study treatment oAgreement to comply with approved methods of
contraception during the period of active study treatment (not required during
- History of organ transplantation
- Known chronic or recurrent systemic disorder associated with immunocompromise
- A history of allergy or hypersensitivity to Saccharomyces boulardii, brewer's or
baker's yeast, amoxicillin, penicillins, or cephalosporins
- History of severe allergic reaction (requiring hospital admission and/or the
administration of parenteral medication or associated with dyspnoea, wheezing,
hypotension, loss of consciousness).
- Oral or systemic antibacterial therapy during the 3 months prior to study enrollment
- New prescription medications during the 4 weeks prior to study enrollment
- Prescription, 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
- Active gastrointestinal disease
- Patients with a central venous catheter
- Patients taking antifungals or laxatives within 14 days of enrolment
- Patients enrolled in other clinical trials within the past 60 days
- Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy)
- History of chronic constipation with passage of fewer than 3 bowel movements per week
- 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.
Locations and Contacts
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
Starting date: April 2012
Last updated: July 22, 2014