Skip to main content
OpenTrials
Completed

NCT Number: NCT07392931

Safety and Efficacy of Racecadotril in Children With Acute Watery Diarrhea

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Watery Diarrhea

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Punjab Rangers Teaching Hospital Lahore

Lahore, Punjab Province, 53720, Pakistan

About this study

Acute watery diarrhea is a leading cause of morbidity and hospitalization among children under five years of age. Although oral rehydration therapy (ORT) remains the cornerstone of management, it does not reduce stool output, frequency, or duration of diarrhea. Racecadotril is an antisecretory agent that reduces intestinal fluid secretion without affecting gastrointestinal motility and has been shown to be safe in pediatric populations.

This study was a single-center, randomized, placebo-controlled clinical trial conducted in the Pediatric Department of Punjab Rangers Teaching Hospital, Lahore. Children aged 3 months to 5 years of either gender presenting with acute watery diarrhea were enrolled after obtaining informed consent from parents or guardians. Acute diarrhea was defined as the passage of three or more watery stools within 24 hours with a duration of less than 72 hours.

Participants were randomized using a lottery method into two groups. The intervention group received racecadotril at a dose of 1.5 mg/kg three times daily as an adjunct to standard oral rehydration therapy and intravenous fluids when indicated. The control group received placebo along with the same standard therapy. The study was conducted under single-blind conditions.

Children with severe dehydration, chronic diarrhea, blood or mucus in stools, age below 3 months, or significant comorbidities were excluded. Clinical outcomes were assessed by monitoring stool frequency, stool consistency, and duration of hospital stay.

The study was conducted over a six-month period from June 2025 to November 2025. Ethical approval was obtained from the Ethical Committee of Punjab Rangers Teaching Hospital, Lahore. Data were analyzed using SPSS software, with results expressed as means, standard deviations, frequencies, and percentages.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children aged 3 months to 5 years Diagnosis of acute watery diarrhea Duration of illness ≤ 72 hours Written informed consent obtained from parents or legal guardians

Exclusion criteria

Chronic diarrhea Severe malnutrition Severe dehydration requiring intensive care Known hypersensitivity to racecadotril Presence of serious underlying systemic illness Patient with bloody mucus containing diarrhea

-

Treatment and study plan

Racecadotril

Drug

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.

Placebo

Other

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

Primary outcomes

  1. Duration of diarrhea

    Time frame: Up to 72 hours after initiation of treatment

    Time from initiation of treatment until passage of the last unformed stool.

  2. Reduction in stool frequency

    Time frame: Within 12 hours of treatment initiation

    Change in the number of watery stools per day after initiation of treatment.

Sponsors and collaborators

Lead sponsor

Punjab Rangers Teaching Hospital Lahore

Other

Registry information

Official study title

Safety and Efficacy of Racecadotril in the Treatment of Acute Watery Diarrhea in Children: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.