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

NCT01414010 | Completed Results

• 1 other identifier: 2010P000319
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Gut Microbiota

Keywords

healthy volunteers; gut microbiota; gut microbiome; prebiotic; probiotic; antibiotic; antibiotic-associated diarrhea; intestinal bacterial overgrowth

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Prebiotic

ACTIVE COMPARATOR

Dietary Supplement: Trametes versicolor extract

Probiotic

ACTIVE COMPARATOR

Dietary Supplement: Saccharomyces boulardii

Antibiotic

ACTIVE COMPARATOR

Drug: Amoxicillin

Control

NO INTERVENTION

Control group, no intervention given.

Interventions

Trametes versicolor extract DIETARY_SUPPLEMENT

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

Also known as: turkey tail

Prebiotic

Saccharomyces boulardii DIETARY_SUPPLEMENT

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

Probiotic

Amoxicillin DRUG

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

Antibiotic

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Hong Kong Association for Health Care: collaborator
• Integrated Chinese Medicine Holdings: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

VPS Coriolus versicolor extract; Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ciaran Kelly, MD
• Organization: Beth Israel Deaconess Medical Center

ckelly2@bidmc.harvard.edu

617-667-1272

Study Officials

• Ciaran P Kelly, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 11, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: July 24, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-06

Locations

US (1)