NCT01473368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

September 9, 2016

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

November 15, 2011

Results QC Date

March 30, 2016

Last Update Submit

March 3, 2017

Conditions

Healthy Volunteers

Keywords

human Gut Microbiotagut microbiotagut microbiomeprobioticantibioticantibiotic-associated diarrheaintestinal bacterial overgrowth

Outcome Measures

Primary Outcomes (6)

  • Gastrointestinal Symptom Rating Scale

    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

    Day 0

  • Gastrointestinal Symptom Rating Scale

    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

    Day 7

  • Gastrointestinal Symptoms Response Score

    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

    Day 14

  • Gastrointestinal Symptoms Response Scale

    Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms

    Day 21

  • 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

  • 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

Study Arms (4)

prebiotic (Saccharomyces boulardii)

ACTIVE COMPARATOR

500 mg, 2 times daily for 14 days

Dietary Supplement: Saccharomyces boulardii

antibiotic (Amoxicillin Clavulanate)

ACTIVE COMPARATOR

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

Drug: Amoxicillin Clavulanate

combination (prebiotic and antibiotic)

ACTIVE COMPARATOR

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 boulardiiDrug: Amoxicillin Clavulanate

control

NO INTERVENTION

Interventions

Saccharomyces boulardiiDIETARY_SUPPLEMENT

500 mg, 2 times daily for 14 days

combination (prebiotic and antibiotic)prebiotic (Saccharomyces boulardii)
Amoxicillin ClavulanateDRUG

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

antibiotic (Amoxicillin Clavulanate)combination (prebiotic and antibiotic)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Kelly CP, Chong Nguyen C, Palmieri LJ, Pallav K, Dowd SE, Humbert L, Seksik P, Bado A, Coffin B, Rainteau D, Kabbani T, Duboc H. Saccharomyces boulardii CNCM I-745 Modulates the Fecal Bile Acids Metabolism During Antimicrobial Therapy in Healthy Volunteers. Front Microbiol. 2019 Mar 4;10:336. doi: 10.3389/fmicb.2019.00336. eCollection 2019.

    PMID: 30881353DERIVED

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Ciaran Kelly, MD
Organization
Beth Israel Deacones Medical Center
ckelly2@bidmc.harvard.edu
617-667-1272

Study Officials

  • Ciaran P Kelly, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 17, 2011

Study Start

April 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 4, 2017

Results First Posted

September 9, 2016

Record last verified: 2017-03

Locations

US(1)