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

Acute Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796480
• Other study ID #: HOSPITAL
• Status: Completed
• Phase: N/A
• Start date: June 10, 2018
• Est. completion date: December 9, 2018

Study information

• Verified date: March 2021
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 9, 2018
• Est. primary completion date: December 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 24 Months

Eligibility

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)

Related Conditions & MeSH terms

• Acute Diarrhea
• Diarrhea

Intervention

Dietary Supplement:
• YOGURT
Group 1 was given yogurt
• LACTOSE FREE FORMULA MILK
Group 2 was given lactose free formula milk

Locations

Country	Name	City	State
Pakistan	Services Hospital Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Chu C, Rotondo-Trivette S, Michail S. Chronic diarrhea. Curr Probl Pediatr Adolesc Health Care. 2020 Aug;50(8):100841. doi: 10.1016/j.cppeds.2020.100841. Epub 2020 Aug 27. — View Citation

Forster CS, Hsieh MH, Cabana MD. Perspectives from the Society for Pediatric Research: Probiotic use in urinary tract infections, atopic dermatitis, and antibiotic-associated diarrhea: an overview. Pediatr Res. 2020 Dec 7. doi: 10.1038/s41390-020-01298-1. [Epub ahead of print] — View Citation

Kosek M, Bern C, Guerrant RL. The global burden of diarrhoeal disease, as estimated from studies published between 1992 and 2000. Bull World Health Organ. 2003;81(3):197-204. Epub 2003 May 16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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