The objectives of this study are to evaluate stool consistency and stool frequency during and up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid 875mg BID.
It is hypothesized that the proportion of subjects having a diarrhea-like defecation, defined as a stool frequency ≥ 3 per day and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days will be lower in the group receiving Lacidofil® STRONG compared to the group receiving placebo and therefore mean Bristol Stool Scores will be lower in subjects receiving Lacidofil® STRONG compared to those receiving placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
160
Lacidofil® STRONG capsule twice daily
Placebo capsule twice daily
KGK Synergize Inc.
London, Ontario, Canada
The primary outcomes are the between group difference in mean Bristol Stool Scores (consistency) and the between group difference in the mean number of bowel movements (frequency).
Time frame: Up to 63 days
Incidence of AAD
Proportion of subjects having diarrhea-like defecation defined as a stool frequency ≥ 3 per a 24 h period and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days (48 h period)
Time frame: Up to 63 days
Influence of Lacidofil® STRONG on side effects associated with antibiotic use
Assessed by Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, bowel habits, adverse effects
Time frame: Up to 63 days
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