Comparing the Efficacy of Anti-secretory Versus Oral Immunoglobulins for Reducing the Episodes of Diarrhea in Children

NCT04885049 | Unknown

• 1 other identifier: No.F.1-1/2015/ERB/SZABMU/556
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children 1-12 years presenting/admitted with acute diarrhea will be enrolled in the study after taking informed consent from the parents. Patients will be randomly allocated to two equal groups. Group A (GA) will receive anti secretory 1.5mg/kg/dose, three doses in 24 hours along with oral rehydration, while Group B (GB) will receive a single dose of bovine immunoglobulins. Response to treatment will be assessed by recording the frequency of loose stools after 72 hrs. Data will be collected through a structured proforma.

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

• frequency of diarrheal episodes

  reduction in frequency of diarrheal episodes after administration of drug

  24 to 72 hours

Study Arms (2)

Group A

EXPERIMENTAL

Group A (GA) will receive anti secretory 1.5mg/kg/dose three doses per oral in 24 hours for 3 days along with oral rehydration

Drug: Racecadotril

Group B

EXPERIMENTAL

Group B (GB) will receive a single dose of bovine colostrum and egg solids as 7 g of dry powder reconstituted in 30 mL of water and taken orally once daily for 3 days along with oral rehydration

Drug: DiaResQ Children's Powder for Suspension

Interventions

Racecadotril DRUG

Anti secretary

Group A

DiaResQ Children's Powder for Suspension DRUG

oral immunoglobulins

Group B

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 1-12 years both male and female visiting/admitted in Children Hospital PIMS with acute diarrhea of less than 15 days duration

You may not qualify if:

• Children requiring emergency resuscitation.
• Children having diarrhea of more than 15 days duration..
• Children with other comorbid conditions like heart, kidney and liver failure.
• Children with fructose intolerance, glucose malabsorption syndrome and saccharase isomaltase deficiency.
• Children allergic to egg or any of the contents.

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

MeSH Terms

Conditions

Diarrhea

Interventions

racecadotril; Suspensions

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Nighat Haider, FCPS

  Shaheed Zulfiqar Ali Bhutto Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nighat Haider, FCPS

CONTACT

+92519107695; nighathaider@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 13, 2021
• Study Start: September 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication of data.
• Access Criteria: If somebody wants the IPD they can email the principal investigator and it will be provided