Effectiveness of Saccharomyces Boulardii in Prevention of Antibiotic Associated Diarrhea

Acute upper respiratory tract infections (URTI) frequently lead to broad-spectrum antibiotic prescriptions such as co-amoxiclav, which can disrupt the gut microbiota and cause antibiotic-associated diarrhea (AAD).

This single-blind randomized controlled trial will be conducted at the Pediatric Medicine Outpatient Department, University of Child Health Sciences, The Children's Hospital, Lahore. A total of 88 children aged 6 months to 5 years presenting with URTI and prescribed co-amoxiclav will be enrolled after obtaining written informed consent from their parents or legal guardians.

Participants will be randomized into two equal groups (n = 44 each):

Group A (Control): Standard dose of oral co-amoxiclav (30 mg/kg/day) for 5 days.

Group B (Intervention): Standard dose of oral co-amoxiclav (30 mg/kg/day) plus oral Saccharomyces boulardii for 5 days.

Clinical response, stool frequency, and stool consistency (graded using the WHO scale) will be assessed telephonically and during clinical follow-up at Day 5 (completion of antibiotic regimen) and at Day 14. Any child developing severe dehydration or high-grade loose stools will be managed in accordance with institutional safety protocols.

Inclusion criteria

• 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

Exclusion criteria

• 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
• Known allergy to co-amoxiclav or the probiotic Saccharomyces boulardii
• Confirmed immunodeficiency disorder or current receipt of immunosuppressive therapy
• History of chronic diarrhea
• Presence of 3rd degree (severe) malnutrition
• Presence of systemic symptoms or infections other than URTI (e.g., lower respiratory tract infection, jaundice)