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

Study Overview
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Saccharomyces boulardii
* Drug: Amoxicillin Clavulanate


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prebiotic (Saccharomyces boulardii)<br>500 mg, 2 times daily for 14 days | Dietary Supplement: Saccharomyces boulardii<br>* 500 mg, 2 times daily for 14 days<br>|
| Active Comparator: antibiotic (Amoxicillin Clavulanate)<br>875/125 mg 2 times daily at least 1 hour before meals for 7 days | Drug: Amoxicillin Clavulanate<br>* 875/125 mg 2 times daily at least 1 hour before meals for 7 days<br>|
| Active Comparator: combination (prebiotic and antibiotic)<br>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). | Dietary Supplement: Saccharomyces boulardii<br>* 500 mg, 2 times daily for 14 days<br>Drug: Amoxicillin Clavulanate<br>* 875/125 mg 2 times daily at least 1 hour before meals for 7 days<br>|
| No Intervention: control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Symptom Rating Scale | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Day 0 | 
| Gastrointestinal Symptom Rating Scale | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Day 7 | 
| Gastrointestinal Symptoms Response Score | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Day 14 | 
| Gastrointestinal Symptoms Response Scale | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Day 21 | 
| Prevalence of Escherichia in Stool | 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 | Day -7 to Day 21 | 
| Operational Taxonomic Units | 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 | Day 0 to Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human Gut Microbiota, gut microbiota, gut microbiome, probiotic, antibiotic, antibiotic-associated diarrhea, intestinal bacterial overgrowth