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

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

Study Overview

• Status: Completed
• Conditions: Acute Watery Diarrhea
• Intervention / Treatment: Drug: Racecadotril; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 53720
      • Punjab Rangers Teaching Hospital Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Racecadotril plus Standard Therapy; Participants received racecadotril in addition to standard therapy, including oral rehydration therapy and intravenous fluids when clinically indicated.	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.
Placebo Comparator: Placebo plus Standard Therapy; Participants received placebo along with standard therapy, including oral rehydration therapy and intravenous fluids when clinically indicated.	Other: Placebo; Placebo was administered orally along with standard therapy for acute watery diarrhea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of diarrhea	Time from initiation of treatment until passage of the last unformed stool.	Up to 72 hours after initiation of treatment
Reduction in stool frequency	Change in the number of watery stools per day after initiation of treatment.	Within 12 hours of treatment initiation

Collaborators and Investigators

• Sponsor: Punjab Rangers Teaching Hospital Lahore
• Investigators: Principal Investigator: Own Abbas, Punjab Rangers Teaching Hospital Lahore

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: January 31, 2026
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Children; Racecadotril; Oral Rehydration Therapy; Acute Gastroenteritis; Pediatric Diarrhea
• Additional Relevant MeSH Terms: racecadotril
• Other Study ID Numbers: RCT-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to ethical and confidentiality considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No