Anti-Secretory Drug in Treatment of Acute Watery Diarrhea

Phase 1

Completed

• Conditions: Acute Watery Diarrhea
• Interventions: Drug: Racecadotril

• Registration Number: NCT05216822
• Lead Sponsor: Assiut University

Brief Summary

In conclusion, racecadotril is an anti-secretory drug that exerts its antidiarrheal effect by inhibiting intestinal enkephalinase. It is effective in reducing the volume and frequency of stool output. racecadotril is well tolerated and safe by providing symptomatic relief and reducing the severity of diarrhea as an adjuvant therapy during the acute attack of gastroenteritis. It is recommended that the new generations of already discovered drugs for control of secretory diarrhea should be studied to discover the ones with fewer side effects to other systems in the body.

Detailed Description

Background: Previous studies have shown that racecadotril is a safe and effective drug in treating children with acute diarrhea. Study Aim: to evaluate the effect of racecadotril as an adjunct to oral rehydration solution in the treatment of acute watery diarrhea among children under 5 years of age. Subjects and methods: This RCT trial included 50 children with acute watery diarrhea for 5 days or less with a frequency of three or more diarrheic stools in the past 24 hours before admission to the hospital, with no/mild to moderate dehydration.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-07-31
• Study Completion: 2018-08-31
• Study First Submitted: 2021-12-06
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-21
• Last Update Submitted: 2022-01-21
• Study First Posted: 2022-02-01
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age group for six months - 5 years.
• No or mild to moderate dehydration.
• Alert patient (to tolerate oral intake since the drug is only available in oral form).

Exclusion Criteria

• Patients with severe dehydration (inability to drink because of drowsiness).
• Patients with any serious concomitant illness that needs antibiotic treatment.
• If severe adverse events occur at any time.
• Chronic diarrhea.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
children received ORS and racecadotril as treatment	Racecadotril	25 children received ORS and racecadotril as treatment (at a dose of 1.5 mg/kg/day, an oral single daily dose for three days)
children received ORS alone as treatment	Racecadotril	25 children received ORS alone for treatment as a control group

Primary Outcome Measures

Name	Time	Method
Diarrheal episode	1-3 months	number

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Asyut, Egypt