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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414010
First Posted: August 11, 2011
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hong Kong Association for Health Care
Integrated Chinese Medicine Holdings
Information provided by (Responsible Party):
Ciaran Kelly, Beth Israel Deaconess Medical Center
  Purpose
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.

Condition Intervention
Human Gut Microbiota Dietary Supplement: Trametes versicolor extract Dietary Supplement: Saccharomyces boulardii Drug: Amoxicillin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Mushroom Extract, S Boulardii and Amoxicillin on the Human Microbiome

Resource links provided by NLM:


Further study details as provided by Ciaran Kelly, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Bacteria Prevalence in Stool [ Time Frame: 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



Enrollment: 32
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prebiotic Dietary Supplement: Trametes versicolor extract
1,200 mg, 3 times daily on an empty stomach for 14 days
Other Name: turkey tail
Active Comparator: Probiotic Dietary Supplement: Saccharomyces boulardii
250 mg, 3 times daily on an empty stomach for 14 days
Active Comparator: Antibiotic Drug: Amoxicillin
250 mg 3 times daily at least 1 hour before meals for 7 days
No Intervention: Control
Control group, no intervention given.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414010


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Hong Kong Association for Health Care
Integrated Chinese Medicine Holdings
Investigators
Principal Investigator: Ciaran P Kelly, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Ciaran Kelly, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01414010     History of Changes
Other Study ID Numbers: 2010P000319
First Submitted: August 5, 2011
First Posted: August 11, 2011
Results First Submitted: December 29, 2015
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017
Last Verified: June 2017

Keywords provided by Ciaran Kelly, Beth Israel Deaconess Medical Center:
healthy volunteers
gut microbiota
gut microbiome
prebiotic
probiotic
antibiotic
antibiotic-associated diarrhea
intestinal bacterial overgrowth

Additional relevant MeSH terms:
Anti-Bacterial Agents
Amoxicillin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents