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

Not Applicable

Completed

Interventions: Drug: Amoxicillin Clavulanate
Dietary Supplement: Saccharomyces boulardii

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
antibiotic (Amoxicillin Clavulanate)	Amoxicillin Clavulanate	875/125 mg 2 times daily at least 1 hour before meals for 7 days
combination (prebiotic and antibiotic)	Saccharomyces boulardii	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).
prebiotic (Saccharomyces boulardii)	Saccharomyces boulardii	500 mg, 2 times daily for 14 days
combination (prebiotic and antibiotic)	Amoxicillin Clavulanate	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).

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Rating Scale	Day 7	Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Gastrointestinal Symptoms Response Score	Day 14	Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Prevalence of Escherichia in Stool	Day -7 to Day 21	Control arm was not assessed as there was no intervention for this group. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21
Gastrointestinal Symptoms Response Scale	Day 21	Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Operational Taxonomic Units	Day 0 to Day 21	Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21