Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota

Healthy Volunteers Clinical Trial

Official title:

Open Label, Randomized Pilot Study to Examine The Effects of the Probiotic Saccharomyces Boulardii, the Antibiotic Amoxicillin/Clavulanate and the Combination on the Gut Microbiota of Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473368
• Other study ID #: 2011-P-000389-Bioclinica
• Status: Completed
• Phase: N/A
• First received: November 15, 2011
• Last updated: September 6, 2016
• Start date: April 2012
• Est. completion date: February 2013

Study information

• Verified date: September 2016
• 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 the probiotic Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the gut microbiota of healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 to 65 years (male or female)

• Good general health

• Able to comply with study requirements and to provide informed consent

• For women of childbearing potential oA negative urine pregnancy test immediately prior to starting the study treatment oAgreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up)

Exclusion Criteria:

• History of organ transplantation

• Known chronic or recurrent systemic disorder associated with immunocompromise

• A history of allergy or hypersensitivity to Saccharomyces boulardii, brewer's or baker's yeast, amoxicillin, penicillins, or cephalosporins

• History of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness).

• Oral or systemic antibacterial therapy during the 3 months prior to study enrollment

• New prescription medications during the 4 weeks prior to study enrollment

• Prescription, 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 disease

• Patients with a central venous catheter

• Patients taking antifungals or laxatives within 14 days of enrolment

• Patients enrolled in other clinical trials within the past 60 days

• Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy)

• History of chronic constipation with passage of fewer than 3 bowel movements per week on average

• 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

• Healthy Volunteers

Intervention

Dietary Supplement:
• Saccharomyces boulardii
500 mg, 2 times daily for 14 days

Drug:
• Amoxicillin Clavulanate
875/125 mg 2 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 (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Biocodex

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal Symptom Rating Scale	Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms	Day 0	No
Primary	Gastrointestinal Symptom Rating Scale	Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms	Day 7	No
Primary	Gastrointestinal Symptoms Response Score	Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms	Day 14	No
Primary	Gastrointestinal Symptoms Response Scale	Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms	Day 21	No
Primary	Prevalence of Escherichia in Stool	Control arm was not assessed as there was no intervention for this group.; Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21	Day -7 to Day 21	No
Primary	Operational Taxonomic Units	Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available.; Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21	Day 0 to Day 21	No