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Completed

NCT Number: NCT04796480

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

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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Key information

Conditions

Acute Diarrhea

Age range

4 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Yogurt

Dietary Supplement

Group 1 was given yogurt

LACTOSE FREE FORMULA MILK

Dietary Supplement

Group 2 was given lactose free formula milk

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Services Hospital, Lahore

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2021
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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