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

A Randomized Controlled Trial Comparing the Efficacy of Anti Secretory and Oral Immunoglobulins Reducing the Episodes of Diarrhea in Children

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diarrhea
• Intervention / Treatment: Drug: Racecadotril; Drug: DiaResQ Children's Powder for Suspension

Detailed Description

It is a randomized clinical trial that will be conducted at Children Hospital PIMS, Islamabad over the period of 6 months. Sample size is calculated using World Health Organization (WHO) calculator, keeping confidence level 95%, level of significance 5%, power of the test 80%,anticipated population proportion 1: 84%, anticipated population proportion 2: 93%, which turn out to be 30.Consecutive non probability sampling technique will be used. Children 1-12 years both male and female visiting/admitted in Children Hospital PIMS with acute diarrhea of less than 15 days duration will be enrolled in the study after taking informed consent from the parents. Children requiring emergency resuscitation, having chronic diarrhea i-e more than 15 days duration, having other comorbid conditions like heart, kidney and liver failure, having metabolic disorder and who are allergic to egg or any of the contents will be excluded from the study.

Child's name, age, sex will be recorded by the on duty doctor. Patients will be randomly allocated to two equal groups. Group A (GA) will receive anti secretory 1.5mg/kg/dose three doses per oral in 24 hours along with oral rehydration, while 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. Response to treatment will be assessed by recording the reduction in frequency of diarrheal episodes after administration of drug and duration in which the diarrheal episodes were reduced. Data will be collected through a structured proforma.

All data will be analyzed using latest SPSS version. Quantitative variables such as age, time will be presented as means and standard deviations. Qualitative variables such as age groups, sex, recurrence of seizures and efficacy will be measured as frequency and percentages. Effect modifiers like age, gender will be controlled by stratification. Post stratification chi-square test will be applied keeping p value ≤0.05 as significant.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nighat Haider, FCPS; Phone Number: +92519107695; Email: nighathaider@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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; Anti secretary
Experimental: Group B; 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; oral immunoglobulins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of diarrheal episodes	reduction in frequency of diarrheal episodes after administration of drug	24 to 72 hours

Collaborators and Investigators

• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
• Investigators: Principal Investigator: Nighat Haider, FCPS, Shaheed Zulfiqar Ali Bhutto Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: May 9, 2021
• First Submitted That Met QC Criteria: May 9, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• 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: No.F.1-1/2015/ERB/SZABMU/556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: If somebody wants the IPD they can email the principal investigator and it will be provided after the publication
• IPD Sharing Time Frame: 6 months after publication of data.
• IPD Sharing Access Criteria: If somebody wants the IPD they can email the principal investigator and it will be provided
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No