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

This study has been completed.
Sponsor:
Collaborators:
Hong Kong Association for Health Care
Integrated Chinese Medicine Holdings
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01414010
First received: August 5, 2011
Last updated: March 7, 2012
Last verified: March 2012
  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: 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 Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Change in microbiome quantity [ Time Frame: Days -28 to -7, 0, 10, 14, 21, 28, 56 ] [ Designated as safety issue: No ]
    Change in total numbers of bacteria in stool samples over the course of the study

  • Change in microbiome diversity [ Time Frame: Days -28 to -7, 0, 10, 14, 21, 28, 56 ] [ Designated as safety issue: No ]
    Change in total numbers of bacterial strains in stool samples as determined by operational taxonomic units over the course of the study


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

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01414010     History of Changes
Other Study ID Numbers: 2010-P-000319
Study First Received: August 5, 2011
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board
United States: Office for Human Research Protections (HHS)

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

Additional relevant MeSH terms:
Amoxicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014