Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota

Condition(s) targeted: Healthy Volunteers

Intervention: Saccharomyces boulardii (Dietary Supplement); Amoxicillin Clavulanate (Drug); Saccharomyces boulardii AND Amoxicillin Clavulanate (Drug)

Phase: N/A

Status: Recruiting

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

Primary outcome:

Change in microbiome quantity

Change in microbiome diversity

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 follow-up)

Exclusion Criteria:

- 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 study enrollment

- 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

on average

- 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.

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Kumar Pallav, MD, Phone: 617-667-8156, Email: kpallav@bidmc.harvard.edu
Josh Hansen, MS, Phone: 617-667-8397, Email: jhansen@bidmc.harvard.edu
Ciaran Kelly, MD, Principal Investigator

Starting date: April 2012
Last updated: July 24, 2012