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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01473368
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : September 9, 2016
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
Biocodex
Information provided by (Responsible Party):
Ciaran Kelly, Beth Israel Deaconess Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Saccharomyces boulardii Drug: Amoxicillin Clavulanate Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Gastrointestinal Symptom Rating Scale [ Time Frame: Day 0 ]
    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

  2. Gastrointestinal Symptom Rating Scale [ Time Frame: Day 7 ]
    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

  3. Gastrointestinal Symptoms Response Score [ Time Frame: Day 14 ]
    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

  4. Gastrointestinal Symptoms Response Scale [ Time Frame: Day 21 ]
    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

  5. Prevalence of Escherichia in Stool [ Time Frame: Day -7 to Day 21 ]

    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


  6. Operational Taxonomic Units [ Time Frame: Day 0 to Day 21 ]

    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



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473368


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Biocodex
Investigators
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Principal Investigator: Ciaran P Kelly, MD Beth Israel Deaconess Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ciaran Kelly, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01473368    
Other Study ID Numbers: 2011P000389
First Posted: November 17, 2011    Key Record Dates
Results First Posted: September 9, 2016
Last Update Posted: April 4, 2017
Last Verified: March 2017
Keywords provided by Ciaran Kelly, Beth Israel Deaconess Medical Center:
human Gut Microbiota
gut microbiota
gut microbiome
probiotic
 antibiotic
antibiotic-associated diarrhea
intestinal bacterial overgrowth
Additional relevant MeSH terms:
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Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
 Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action