Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota
This study is ongoing, but not recruiting participants.
Sponsor:
Beth Israel Deaconess Medical Center
Collaborator:
Biocodex
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01473368
First received: November 15, 2011
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy Volunteers |
Dietary Supplement: Saccharomyces boulardii Drug: Amoxicillin Clavulanate Drug: Saccharomyces boulardii AND Amoxicillin Clavulanate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
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, 3, 6, 10, 13, 21 ] [ 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, 3, 6, 10, 13, 21 ] [ 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
| Estimated Enrollment: | 48 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: prebiotic (Saccharomyces boulardii) |
Dietary Supplement: Saccharomyces boulardii
500 mg, 2 times daily for 14 days
|
| Active Comparator: antibiotic (Amoxicillin Clavulanate) |
Drug: Amoxicillin Clavulanate
875/125 mg 2 times daily at least 1 hour before meals for 7 days
|
| Active Comparator: combination (prebiotic and antibiotic) |
Drug: Saccharomyces boulardii AND Amoxicillin Clavulanate
Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
|
| No Intervention: control |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473368
Locations
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Biocodex
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: | NCT01473368 History of Changes |
| Other Study ID Numbers: | 2011-P-000389-Bioclinica |
| Study First Received: | November 15, 2011 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Office for Human Research Protections (HHS) |
Keywords provided by Beth Israel Deaconess Medical Center:
|
human Gut Microbiota gut microbiota gut microbiome probiotic |
antibiotic antibiotic-associated diarrhea intestinal bacterial overgrowth |
Additional relevant MeSH terms:
|
Amoxicillin Anti-Bacterial Agents Amoxicillin-Potassium Clavulanate Combination Clavulanic Acids Clavulanic Acid |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013