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Completed

NCT Number: NCT01473368

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saccharomyces boulardii

Dietary Supplement

500 mg, 2 times daily for 14 days

amoxicillin clavulanate

Drug

875/125 mg 2 times daily at least 1 hour before meals for 7 days

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Biocodex

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 17, 2011
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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