NCT07392931

Safety and Efficacy of Racecadotril in Children With Acute Watery Diarrhea

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Punjab Rangers Teaching Hospital Lahore · Academic / Other
• Sex: All
• Age: 3 Months – 5 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Acute Watery Diarrhea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: Pakistan