Effects of Pre-, Pro- & Anti-biotics 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 a prebiotic (Trametes Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut microbiota of healthy volunteers. It is expected that treatment will result in the rapid and reproducible alterations in fecal microbiota that will spontaneously reverse in the weeks after treatment is discontinued.

Official Title
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Effects of Mushroom Extract, S Boulardii and Amoxicillin on the Human Microbiome

Conditions
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Human Gut Microbiota

Intervention / Treatment
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* Dietary Supplement: Trametes versicolor extract
* Dietary Supplement: Saccharomyces boulardii
* Drug: Amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 39 years (male or female) Good general health Able to comply with study requirements and to provide informed consent For women of childbearing potential A negative urine pregnancy test immediately prior to starting the study treatment Agreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up) Exclusion Criteria: Any diagnosed autoimmune disease History of organ transplantation Known chronic or recurrent systemic disorder associated with immunocompromise A history of allergy or hypersensitivity to mushroom or mushroom extract, brewer's or baker's yeast or to penicillins or cephalosporins (including amoxicillin). History of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness). Systemic antibacterial therapy during the 3 months prior to study enrollment New prescription medications during the 4 weeks prior to study enrollment Prescription or 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 or metabolic disease Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy) History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily 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: 39 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<br> | Dietary Supplement: Trametes versicolor extract<br>* 1,200 mg, 3 times daily on an empty stomach for 14 days<br>* Other names: turkey tail;|
| Active Comparator: Probiotic<br> | Dietary Supplement: Saccharomyces boulardii<br>* 250 mg, 3 times daily on an empty stomach for 14 days<br>|
| Active Comparator: Antibiotic<br> | Drug: Amoxicillin<br>* 250 mg 3 times daily at least 1 hour before meals for 7 days<br>|
| No Intervention: Control<br>Control group, no intervention given. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteria Prevalence in Stool | The most prevalent bacterial genera within the study population Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56 | Day 0 to 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers, gut microbiota, gut microbiome, prebiotic, probiotic, antibiotic, antibiotic-associated diarrhea, intestinal bacterial overgrowth