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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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prebiotic (Saccharomyces boulardii)

500 mg, 2 times daily for 14 days

Group Type ACTIVE_COMPARATOR

Saccharomyces boulardii

Intervention Type DIETARY_SUPPLEMENT

500 mg, 2 times daily for 14 days

antibiotic (Amoxicillin Clavulanate)

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

Group Type ACTIVE_COMPARATOR

Amoxicillin Clavulanate

Intervention Type DRUG

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

combination (prebiotic and antibiotic)

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).

Group Type ACTIVE_COMPARATOR

Saccharomyces boulardii

Intervention Type DIETARY_SUPPLEMENT

500 mg, 2 times daily for 14 days

Amoxicillin Clavulanate

Intervention Type DRUG

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

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Saccharomyces boulardii

500 mg, 2 times daily for 14 days

Intervention Type DIETARY_SUPPLEMENT

Amoxicillin Clavulanate

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes