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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-10

Study Completion Date

2018-12-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were divided in 2 groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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YOGURT

Group 1 children were given home made plain yogurt in treatment of acute diarrhea

Group Type ACTIVE_COMPARATOR

YOGURT

Intervention Type DIETARY_SUPPLEMENT

Group 1 was given yogurt

LACTOSE FREE FORMULA MILK

Group 2 children were given lactose free formula milk in treatment of acute diarrhea

Group Type ACTIVE_COMPARATOR

LACTOSE FREE FORMULA MILK

Intervention Type DIETARY_SUPPLEMENT

Group 2 was given lactose free formula milk

Interventions

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YOGURT

Group 1 was given yogurt

Intervention Type DIETARY_SUPPLEMENT

LACTOSE FREE FORMULA MILK

Group 2 was given lactose free formula milk

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

4 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No