Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota

Not Applicable

Completed

• Conditions: Human Gut Microbiota
• Interventions: Dietary Supplement: Trametes versicolor extract; Dietary Supplement: Saccharomyces boulardii; Drug: Amoxicillin

• Registration Number: NCT01414010
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2015-12-29
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-25
• Last Update Submitted: 2017-06-25
• Results First Posted: 2017-07-24
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prebiotic	Trametes versicolor extract	-
Probiotic	Saccharomyces boulardii	-
Antibiotic	Amoxicillin	-

Primary Outcome Measures

Name	Time	Method
Bacteria Prevalence in Stool	Day 0 to 56	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

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States