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Completed

NCT Number: NCT05216822

Anti-Secretory Drug in Treatment of Acute Watery Diarrhea

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.

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Key information

Conditions

Acute Watery Diarrhea

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Assiut University

Asyut, 71511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Racecadotril

Drug

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

Other names: Acetorphan

Primary outcomes

  1. Diarrheal episode

    Time frame: 1-3 months

    number

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2022
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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