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

NCT04796480 | Completed DMC

• 1 other identifier: HOSPITAL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Diarrhea

Keywords

LACTOSE FREE FORMULA MILK; YOGURT

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

YOGURT

ACTIVE COMPARATOR

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

Dietary Supplement: YOGURT

LACTOSE FREE FORMULA MILK

ACTIVE COMPARATOR

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

Dietary Supplement: LACTOSE FREE FORMULA MILK

Interventions

YOGURT DIETARY_SUPPLEMENT

Group 1 was given yogurt

YOGURT

LACTOSE FREE FORMULA MILK DIETARY_SUPPLEMENT

Group 2 was given lactose free formula milk

LACTOSE FREE FORMULA MILK

Eligibility Criteria

• Age: 4 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of age 4-24 months presenting with acute diarrhea
• Both gender

You may not qualify if:

• 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)

Sponsors & Collaborators

• Services Hospital, Lahore: lead

Study Sites (1)

Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 12764516 BACKGROUND

• 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.

  PMID: 32863166 BACKGROUND

• 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. 2021 Aug;90(2):315-327. doi: 10.1038/s41390-020-01298-1. Epub 2020 Dec 7.

  PMID: 33288875 BACKGROUND

MeSH Terms

Interventions

Yogurt

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were divided in 2 groups.

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 15, 2021
• Study Start: June 10, 2018
• Primary Completion: December 9, 2018
• Study Completion: December 9, 2018
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)