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

Not Applicable

Completed

• Conditions: Acute Diarrhea
• Interventions: Dietary Supplement: YOGURT; Dietary Supplement: LACTOSE FREE FORMULA MILK

• Registration Number: NCT04796480
• Lead Sponsor: Services Hospital, Lahore

Brief Summary

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.

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 Timeline

• Study Start: 2018-06-10
• Primary Completion: 2018-12-09
• Study Completion: 2018-12-09
• Status Verified: 2021-03
• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-10
• Last Update Submitted: 2021-03-14
• Study First Posted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YOGURT	YOGURT	Group 1 children were given home made plain yogurt in treatment of acute diarrhea
LACTOSE FREE FORMULA MILK	LACTOSE FREE FORMULA MILK	Group 2 children were given lactose free formula milk in treatment of acute diarrhea

Primary Outcome Measures

Name	Time	Method
Effect of home-made yogurt versus lactose-free milk on mean duration of diarrhea in children with acute diarrhea	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.

Trial Locations

Locations (1)

Services Hospital Lahore; 🇵🇰 Lahore, Punjab, Pakistan