Anti-Secretory Drug in Treatment of Acute Watery Diarrhea

Role of Anti-Secretory Drug in Treatment of Children With Acute Watery Diarrhea

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05216822

Enrollment

Registered

2022-02-01

Start date

2018-06-01

Completion date

2018-08-31

Last updated

2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Watery Diarrhea

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.

Interventions

DRUGRacecadotril

racecadotril (dose of 1.5 mg/kg/day, an oral single daily dose for three days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 5 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Diarrheal episode	1-3 months	number

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026