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Safety and Efficacy of Racecadotril in Children With Acute Watery Diarrhea

NCT07392931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-02-06

No results posted yet for this study

Summary

Acute watery diarrhea is a common cause of illness and hospitalization in children under five years of age, particularly in developing countries. The mainstay of treatment is oral rehydration therapy, which prevents dehydration but does not reduce stool frequency or duration of diarrhea. Persistent diarrhea often leads to repeated hospital visits and increased healthcare burden.

This randomized controlled trial was conducted to evaluate the safety and efficacy of racecadotril as an adjunct to standard oral rehydration therapy in children aged 3 months to 5 years hospitalized with acute watery diarrhea. Participants were randomly assigned to receive either racecadotril in addition to standard therapy or placebo with standard therapy.

The primary outcomes assessed were reduction in stool frequency and improvement in stool consistency, along with duration of hospital stay. The study aimed to determine whether racecadotril provides additional clinical benefit when used alongside standard treatment in pediatric acute watery diarrhe

Conditions

  • Acute Watery Diarrhea

Interventions

DRUG

Racecadotril

Racecadotril was administered orally at a dose of 1.5 mg/kg three times daily as an adjunct to standard therapy for acute watery diarrhea.

OTHER

Placebo

Placebo was administered orally along with standard therapy for acute watery diarrhea.

Sponsors & Collaborators

  • Punjab Rangers Teaching Hospital Lahore

    lead OTHER

Principal Investigators

  • Own Abbas · Punjab Rangers Teaching Hospital Lahore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07392931 on ClinicalTrials.gov