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Completed

NCT Number: NCT01414010

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

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trametes versicolor extract

Dietary Supplement

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

Other names: turkey tail

Saccharomyces boulardii

Dietary Supplement

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

Amoxicillin

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Hong Kong Association for Health Care
  • Integrated Chinese Medicine Holdings

Registry information

Official study title

Effects of Mushroom Extract, S Boulardii and Amoxicillin on the Human Microbiome

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 11, 2011
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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