Comparison Of Outcome Of Lactose Free Formula Milk With Yogurt In Children With Acute Diarrhea

March 14, 2021 updated by: Dr. Mahjabeen Akram, Services Hospital, Lahore
This study was aimed to look at the effect of lactose free formula milk in comparison with home-made plain yogurt in children with acute watery diarrhea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial using non probability consecutive sampling was carried out on 60 children (30 in each group) in Department of Paediatrics Unit I, Services Hospital Lahore. An informed written consent was taken from parents of the children. Ethical issues considered and maintained throughout the study. Then all children were randomly divided in two groups by using lottery method. In group 1; children were given yogurt while in group 2, children were given lactose free formula milk. In both groups, feed was given 5-8 times per day. Patients were followed-up till resolution of symptoms and discharge from hospital.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Services Hospital Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children of age 4-24 months presenting with acute diarrhea
  • Both gender

Exclusion Criteria:

  • Children on antibiotic therapy within 48 hours prior to presentation
  • Malnourished children (-2SD as per WHO criteria)
  • Children with severe dehydration requiring IV fluids
  • Children < 4 months of age (as weaning not started yet)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: YOGURT
Group 1 children were given home made plain yogurt in treatment of acute diarrhea
Dietary supplement: YOGURT
Group 1 was given yogurt
ACTIVE_COMPARATOR: LACTOSE FREE FORMULA MILK
Group 2 children were given lactose free formula milk in treatment of acute diarrhea
Dietary supplement: LACTOSE FREE FORMULA MILK
Group 2 was given lactose free formula milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of home-made yogurt versus lactose-free milk on mean duration of diarrhea in children with acute diarrhea
Time Frame: 6 Months
The effect of home-made yogurt and lactose-free milk in children with acute diarrhea was compared i.e. to check out which one is more suitable to treat diarrhea by measuring the mean duration of diarrhea in hours. The reason behind the effectiveness of yogurt against lactose-free milk is the presence of probiotics within it, which help in recovering of good bacteria population in intestine and so may help in decreasing duration and severity of diarrhea.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Hospital, Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 10, 2018

Primary Completion (ACTUAL)

December 9, 2018

Study Completion (ACTUAL)

December 9, 2018

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (ACTUAL)

March 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 14, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOSPITAL

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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