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

Study Overview
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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.

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.

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

Conditions
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Acute Diarrhea

Intervention / Treatment
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* Dietary Supplement: YOGURT
* Dietary Supplement: LACTOSE FREE FORMULA MILK


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were divided in 2 groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: YOGURT<br>Group 1 children were given home made plain yogurt in treatment of acute diarrhea | Dietary Supplement: YOGURT<br>* Group 1 was given yogurt<br>|
| Active Comparator: LACTOSE FREE FORMULA MILK<br>Group 2 children were given lactose free formula milk in treatment of acute diarrhea | Dietary Supplement: LACTOSE FREE FORMULA MILK<br>* Group 2 was given lactose free formula milk<br>|

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LACTOSE FREE FORMULA MILK, YOGURT