An interventional study of Co-amoxiclav and Saccharomyces boulardii in Antibiotic Associated Diarrhea and Upper Respiratory Tract Infection, sponsored by University of Child Health Sciences and Children's Hospital, Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by University of Child Health Sciences and Children's Hospital, Lahore · Not applicable, Interventional, and Prevention
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.
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.
753 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
This study's planned enrollment of 88 is below the median of 200 across 542 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →University of Child Health Sciences and Children's Hospital, Lahore is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard oral co-amoxiclav (30 mg/kg/day) for 5 days.
Drug: Co-amoxiclav
Participants receive standard oral co-amoxiclav (30 mg/kg/day) plus oral Saccharomyces boulardii for 5 days.
Drug: Co-amoxiclav · Dietary Supplement: Saccharomyces boulardii
30 mg/kg/day orally for 5 days.
Administered 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.
Time frame: From initiation of treatment through Day 14
Stool Frequency
Number of stool passages per day categorized on a standardized scale (Nil, 1-2, 3-4, \>4 times per day).
Time frame: Assessed at Day 1, Day 5, and Day 14.
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).
Time frame: Assessed at Day 1, Day 5, and Day 14
Duration of Diarrhea
Total duration (in days) of diarrheal episodes in participants who develop antibiotic-associated diarrhea.
Time frame: Up to Day 14 post-initiation of therapy
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 119 non-industry interventional studies with no phase under Respiratory Tract Infections, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's planned 5 months is below that.
Counting every sponsor, half of 146 studies reached it within 12 months; a quarter within 6 and three quarters within 29.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Saccharomyces cerevisiae
Respiratory Tract Infections →
University of Child Health Sciences and Children's Hospital, Lahore