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

Human Gut Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414010
• Other study ID #: 2010-P-000319
• Status: Completed
• Phase: N/A
• First received: August 5, 2011
• Last updated: March 7, 2012
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Office for Human Research Protections (HHS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Human Gut Microbiota

Intervention

Dietary Supplement:
• Trametes versicolor extract
1,200 mg, 3 times daily on an empty stomach for 14 days
• 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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Hong Kong Association for Health Care, Integrated Chinese Medicine Holdings

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microbiome quantity	Change in total numbers of bacteria in stool samples over the course of the study	Days -28 to -7, 0, 10, 14, 21, 28, 56	No
Primary	Change in microbiome diversity	Change in total numbers of bacterial strains in stool samples as determined by operational taxonomic units over the course of the study	Days -28 to -7, 0, 10, 14, 21, 28, 56	No