Racecadotril Versus Standard Treatment in Decreasing the Duration of Acute Diarrhoea in Children (ERADICATE)

Efficacy of Racecadotril in Addition to Standard Treatment i in Decreasing the Duration of Acute Diarrhoea in Children as Compared to Standard of Treatment Alone

Acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per WHO classification. The study's outcome variables are stool frequency, measured by the total number of stools passed during 24 and 48 hours from the initiation of treatment, and hospital duration, measured by the total duration of hospital stay in hours. The null hypothesis states that racecadotril combined with standard treatment has no effect on reducing the mean number of stools passed during 48 hours compared to standard treatment alone in pediatric patients with acute watery diarrhea, while the alternate hypothesis suggests that racecadotril combined with standard treatment will significantly reduce the mean number of stools passed during 48 hours compared to standard treatment alone in these patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Diarrhoea
• Intervention / Treatment: Drug: Racecadotril

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Aqsa Jabeen Jabeen, MBBS; Phone Number: 03327148228; Email: aqsajabeen2010@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hospitalized Patients with acute watery diarrhea of both genders who are

  1. Age: 03 months to 05 years

  2. Present in first 24 hours of onset of disease.

     Exclusion Criteria:

  1. Parenteral Diarrhea
  2. Chronic Diarrhea like Coeliac disease, Lactose intolerance
  3. Mal-absorption Syndromes
  4. Diarrhea related to food poisoning, dysentery as suggested by history
  5. Severe dehydration patents who are vitally unstable.
  6. Diarrhea associated with measles.
  7. Persistent vomiting
  8. Abdominal distention
  9. Patients allergic to racecadotril
  10. Patients managed before enrolled to study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group receiving (racecadotril+ORS+Zinc); The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone	Drug: Racecadotril; The intervention group will receive racecadotril+ORS+Zinc; Other Names: ORS+Zinc
Active Comparator: the control group (receiving ORS + Zinc or standard treatment); The intervention group will receive racecadotril+ORS+Zinc while the reference group will receive ORS+Zinc alone	Drug: Racecadotril; The intervention group will receive racecadotril+ORS+Zinc; Other Names: ORS+Zinc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool frequency	Total no. of stools passed during 24 and 48 hours from initiation of treatment will be compared between two groups	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Duration	Total duration of hospital stay taken in hours	48 Hours

Collaborators and Investigators

• Sponsor: Liaquat National Hospital & Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): August 2, 2024
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): December 2, 2024

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Diarrhoea; Stool; Paediatrics
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protease Inhibitors; Antidiarrheals; Racecadotril
• Other Study ID Numbers: R-30/RMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No