MedTrace Logo

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

NCT01414010 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-07-24

Study results available
· View outcomes & findings →

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.

Conditions

  • Human Gut Microbiota

Interventions

DIETARY_SUPPLEMENT

Trametes versicolor extract

1,200 mg, 3 times daily on an empty stomach for 14 days

DIETARY_SUPPLEMENT

Saccharomyces boulardii

250 mg, 3 times daily on an empty stomach for 14 days

DRUG

Amoxicillin

250 mg 3 times daily at least 1 hour before meals for 7 days

Sponsors & Collaborators

Principal Investigators

  • Ciaran P Kelly, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01414010 on ClinicalTrials.gov