Efficacy and safety of racecadotril in treatment of acute diarrhea in children 1 months to 5-years

Efficacy and safety of enkefalinase inhibitor racecadotril in decreasing the duration and frequency of acute diarrhea in children 1 months to 5 years

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201607131264N8

Enrollment

100

Registered

2017-05-12

Start date

2016-06-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

acute diarrhea. Gastroenteritis and colitis of unspecified origin

Interventions

Intervention 1: Serum therapy (MANA protocol and WHO guidelines) and Racecadotril (1.5 mg per kg 3 doses in day for 5 days or when no diarrhea). Intervention 2: Only serum therapy.

Treatment - Drugs

Serum therapy (MANA protocol and WHO guidelines) and Racecadotril (1.5 mg per kg 3 doses in day for 5 days or when no diarrhea)

Only serum therapy

Eligibility

Sex/Gender

All

Age

1 Months to 5 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children 1 months to 5 years old; acute diarrhea Exclusion criteria: children younger than 1 months-old and older than 5 years-old; renal or hepatic failure; history of allergy to any medication

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Duration of diarrhea. Timepoint: days. Method of measurement: medical record.;Frequency of diarrhea. Timepoint: daily. Method of measurement: numbers of defecation in 24 hours.	—

Secondary

Measure	Time frame
Duration of hospital stay. Timepoint: days. Method of measurement: medical record.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Farid Imanzadeh

Shahid Beheshti University of Medical Sciences

drimanzadeh@yahoo.com+98 21222270218

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026