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

This study has been completed.
Sponsor:
Collaborator:
Biocodex
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01473368
First received: November 15, 2011
Last updated: September 6, 2016
Last verified: September 2016
  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

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:
  • Gastrointestinal Symptom Rating Scale [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

  • Gastrointestinal Symptom Rating Scale [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

  • Gastrointestinal Symptoms Response Score [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

  • Gastrointestinal Symptoms Response Scale [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

  • Prevalence of Escherichia in Stool [ Time Frame: Day -7 to Day 21 ] [ Designated as safety issue: No ]

    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


  • Operational Taxonomic Units [ Time Frame: Day 0 to Day 21 ] [ Designated as safety issue: No ]

    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



Enrollment: 53
Study Start Date: April 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: prebiotic (Saccharomyces boulardii)
500 mg, 2 times daily for 14 days
Dietary Supplement: Saccharomyces boulardii
500 mg, 2 times daily for 14 days
Active Comparator: antibiotic (Amoxicillin Clavulanate)
875/125 mg 2 times daily at least 1 hour before meals for 7 days
Drug: Amoxicillin Clavulanate
875/125 mg 2 times daily at least 1 hour before meals for 7 days
Active Comparator: combination (prebiotic and antibiotic)
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).
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
No Intervention: control

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
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: 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

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
Results First Received: March 30, 2016
Last Updated: September 6, 2016
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:
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 08, 2016