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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
53
500 mg, 2 times daily for 14 days
875/125 mg 2 times daily at least 1 hour before meals for 7 days
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Gastrointestinal Symptom Rating Scale
Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Time frame: Day 0
Gastrointestinal Symptom Rating Scale
Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Time frame: Day 7
Gastrointestinal Symptoms Response Score
Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Time frame: Day 14
Gastrointestinal Symptoms Response Scale
Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Time frame: 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
Time frame: 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
Time frame: Day 0 to Day 21
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