This is randomized, double-blind, placebo controlled, single centre; 21 days phase II clinical trial on healthy volunteers. Following baseline visit at the day of randomization, treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic treatment subjects will also receive the study treatment, either probiotic or placebo. Daily Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect fecal samples for microbiological examination. The primary objective of the study is to evaluate the maintenance of intestinal microbiota composition during antibiotic treatment with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects associated with antibiotic use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
Probiotic capsule once daily
Placebo capsule once daily
KGK Synergize Inc.
London/Ontario, Canada
Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg
Fecal samples collected during the 3 week period and stored frozen until analyses. Bacterial DNA is extracted from the samples and the microbial composition is analysed by molecular methods such as quantitative PCR.
Time frame: 3 weeks
The influence of probiotics on side effects associated with antibiotic use
Questionaire is used to assess the tolerability of the probiotic supplementation, Bowel habit scores, adverse effects,
Time frame: 3-weeks
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