Anti-Secretory Drug in Treatment of Acute Watery Diarrhea

Assiut University

Status and phase: Completed; Phase 1

Conditions: Acute Watery Diarrhea

Treatments: Drug: Racecadotril

Study type: Interventional

Funder types: Other

Identifiers

NCT05216822

IRB-2/2019AZA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

children received ORS and racecadotril as treatment

Experimental group

Description:

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)

Treatment:

Drug: Racecadotril

children received ORS alone as treatment

Active Comparator group

Description:

25 children received ORS alone for treatment as a control group

Treatment:

Drug: Racecadotril