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

Beth Israel Lahey Health

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Saccharomyces boulardii; Drug: Amoxicillin Clavulanate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01473368

2011P000389

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 4 patient groups

prebiotic (Saccharomyces boulardii)

Active Comparator group

Description:

500 mg, 2 times daily for 14 days

Treatment:

Dietary Supplement: Saccharomyces boulardii

antibiotic (Amoxicillin Clavulanate)

Active Comparator group

Description:

875/125 mg 2 times daily at least 1 hour before meals for 7 days

Treatment:

Drug: Amoxicillin Clavulanate

combination (prebiotic and antibiotic)

Active Comparator group

Description:

Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).

Treatment:

Dietary Supplement: Saccharomyces boulardii

Drug: Amoxicillin Clavulanate

control

No Intervention group