Antibiotic Associated Diarrhea, Upper Respiratory Tract Infection
Conditions
Keywords
Saccharomyces boulardii, Probiotics, Co-amoxiclav, Pediatrics, Diarrhea Prevention
Brief summary
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.
Detailed description
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.
Interventions
DRUGCo-amoxiclav
30 mg/kg/day orally for 5 days.
DIETARY_SUPPLEMENTSaccharomyces boulardii
Administered orally alongside standard co-amoxiclav for 5 days.
Sponsors
University of Child Health Sciences and Children's Hospital, Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Antibiotic-Associated Diarrhea (AAD) | From initiation of treatment through Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool Frequency | Assessed at Day 1, Day 5, and Day 14. | Number of stool passages per day categorized on a standardized scale (Nil, 1-2, 3-4, \>4 times per day). |
| Stool Consistency Grade | Assessed at Day 1, Day 5, and Day 14 | 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 | Up to Day 14 post-initiation of therapy | Total duration (in days) of diarrheal episodes in participants who develop antibiotic-associated diarrhea. |
Countries
Pakistan
Contacts
CONTACTGul Jabeen, MBBS
Outcome results
None listed