Antibiotic Associated DiarrheaNCT07785206
Effectiveness of Saccharomyces Boulardii in Prevention of Antibiotic Associated Diarrhea
A study testing Co-amoxiclav and Saccharomyces boulardii in people with Antibiotic Associated Diarrhea and Upper Respiratory Tract Infection, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Antibiotic Associated Diarrhea, Upper Respiratory Tract Infection
- What is being tested?
- Co-amoxiclav and Saccharomyces boulardii
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2026to May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
University of Child Health sciences, Children's hospital,Lahore
Lahore, Punjab Province
Gul Jabeen, MBBS, +923330937322, aabigul96@gmail.com
About this study
Official title: Effectiveness of Saccharomyces Boulardii in the Prevention of Antibiotic-Associated Diarrhea Among Children Receiving Co-amoxiclav for Upper Respiratory Tract Infection: A Randomized Control Trial
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.
Read the 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.
- Being tested
- Co-amoxiclav, Saccharomyces boulardii
- Keywords
- Saccharomyces boulardii, Probiotics, Co-amoxiclav, Pediatrics, Diarrhea Prevention
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-amoxiclavDrug
30 mg/kg/day orally for 5 days.
Saccharomyces boulardiiDietary supplement
Administered orally alongside standard co-amoxiclav for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Control Group | Active comparator | Participants receive standard oral co-amoxiclav (30 mg/kg/day) for 5 days. Receives: Drug: Co-amoxiclav |
| Group B:Intervention Group | Experimental | Participants receive standard oral co-amoxiclav (30 mg/kg/day) plus oral Saccharomyces boulardii for 5 days. Receives: Drug: Co-amoxiclav; Dietary Supplement: Saccharomyces boulardii |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initiation of treatment through Day 14
Secondary outcomes (3)
Stool Frequency
Number of stool passages per day categorized on a standardized scale (Nil, 1-2, 3-4, >4 times per day).
Measured: 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).
Measured: 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.
Measured: Up to Day 14 post-initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Jabeen, University of Child Health Sciences and Children's Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785206
- Sponsor's protocol ID
- UCHS-MD-01
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No