Clinical trial NCT01473368: Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: human Gut Microbiota
gut microbiota
gut microbiome
probiotic
antibiotic
antibiotic-associated diarrhea
intestinal bacterial overgrowth
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Biocodex
First posted: 2011-11-17
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Gastrointestinal Symptom Rating Scale
timeFrame: Day 0
measure: Gastrointestinal Symptom Rating Scale
timeFrame: Day 7
measure: Gastrointestinal Symptoms Response Score
timeFrame: Day 14
measure: Gastrointestinal Symptoms Response Scale
timeFrame: Day 21
measure: Prevalence of Escherichia in Stool
timeFrame: Day -7 to Day 21
measure: Operational Taxonomic Units
timeFrame: Day 0 to Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Ciaran P Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.