Safety and Efficacy of Racecadotril in Children With Acute Watery Diarrhea

NCT07392931 | Completed

• 1 other identifier: RCT-2026-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Racecadotril; Pediatric Diarrhea; Acute Gastroenteritis; Oral Rehydration Therapy; Children

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Racecadotril plus Standard Therapy

EXPERIMENTAL

Participants received racecadotril in addition to standard therapy, including oral rehydration therapy and intravenous fluids when clinically indicated.

Drug: Racecadotril

Placebo plus Standard Therapy

PLACEBO COMPARATOR

Participants received placebo along with standard therapy, including oral rehydration therapy and intravenous fluids when clinically indicated.

Other: Placebo

Interventions

Placebo OTHER

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

Placebo plus Standard Therapy

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.

Racecadotril plus Standard Therapy

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Punjab Rangers Teaching Hospital Lahore: lead

Study Sites (1)

Punjab Rangers Teaching Hospital Lahore

Lahore, Punjab Province, 53720, Pakistan

Location

MeSH Terms

Interventions

racecadotril

Study Officials

• Own Abbas

  Punjab Rangers Teaching Hospital Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This was a single-blind study in which participants were unaware of treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Own Abbas

Model Details: A randomized, parallel-group, placebo-controlled clinical trial comparing racecadotril plus standard therapy with placebo plus standard therapy in children with acute watery diarrhea

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 6, 2026
• Study Start: June 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)