Antibiotic-associated diarrhea (AAD) is a common adverse effect in pediatric patients receiving broad-spectrum antibiotics such as co-amoxiclav for upper respiratory tract infections (URTI). This study aims to evaluate the effectiveness of the probiotic Saccharomyces boulardii in preventing antibiotic-associated diarrhea among children aged 6 months to 5 years receiving co-amoxiclav. Participants will be randomly allocated to receive either standard co-amoxiclav therapy alone or co-amoxiclav combined with Saccharomyces boulardii for 5 days. The primary objective is to evaluate whether the addition of Saccharomyces boulardii reduces the incidence of diarrhea during and up to 14 days following antibiotic therapy.
Children aged 6 months to 5 years presenting with upper respiratory tract infection (URTI)
Prescribed standard oral co-amoxiclav therapy
Both male and female patients
Written informed consent provided by parents or legal guardians
Presence of diarrhea at the time of study enrollment
Prior use of probiotics during the current course of illness
Receipt of any antibiotic other than co-amoxiclav within the 72 hours preceding enrollment
Concomitant use of other medications
Parallel
Co-amoxiclav
Drug30 mg/kg/day orally for 5 days.
Saccharomyces boulardii
Dietary supplementAdministered orally alongside standard co-amoxiclav for 5 days.
Incidence of Antibiotic-Associated Diarrhea (AAD)
Proportion of participants who develop antibiotic-associated diarrhea, defined as 3 or more unformed/loose stools per day or a single episode of watery stool starting at least 2 hours post-initiation of co-amoxiclav therapy.
Stool Frequency
Number of stool passages per day categorized on a standardized scale (Nil, 1-2, 3-4, \>4 times per day).
Stool Consistency Grade
Stool consistency graded according to the WHO grading scale: Grade 1 (Normal formed), Grade 2 (Semi-formed), Grade 3 (Liquid stools taking shape of container), Grade 4 (Watery stools with flakes, opaque), Grade 5 (Watery stools with few flakes, translucent).
Duration of Diarrhea
Total duration (in days) of diarrheal episodes in participants who develop antibiotic-associated diarrhea.
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