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

Primary Purpose

Acute Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
YOGURT
LACTOSE FREE FORMULA MILK
Sponsored by
Services Hospital, Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Diarrhea focused on measuring LACTOSE FREE FORMULA MILK, YOGURT

Eligibility Criteria

4 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Services Hospital Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

YOGURT

LACTOSE FREE FORMULA MILK

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2021
Last Updated
March 14, 2021
Sponsor
Services Hospital, Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT04796480
Brief Title
Comparison Of Outcome Of Lactose Free Formula Milk With Yogurt In Children With Acute Diarrhea
Official Title
Comparison Of Outcome Of Lactose Free Formula Milk With Yogurt In Children With Acute Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2018 (Actual)
Primary Completion Date
December 9, 2018 (Actual)
Study Completion Date
December 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diarrhea
Keywords
LACTOSE FREE FORMULA MILK, YOGURT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were divided in 2 groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YOGURT
Arm Type
Active Comparator
Arm Description
Group 1 children were given home made plain yogurt in treatment of acute diarrhea
Arm Title
LACTOSE FREE FORMULA MILK
Arm Type
Active Comparator
Arm Description
Group 2 children were given lactose free formula milk in treatment of acute diarrhea
Intervention Type
Dietary Supplement
Intervention Name(s)
YOGURT
Intervention Description
Group 1 was given yogurt
Intervention Type
Dietary Supplement
Intervention Name(s)
LACTOSE FREE FORMULA MILK
Intervention Description
Group 2 was given lactose free formula milk
Primary Outcome Measure Information:
Title
Effect of home-made yogurt versus lactose-free milk on mean duration of diarrhea in children with acute diarrhea
Description
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.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Services Hospital Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12764516
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.
Results Reference
background
PubMed Identifier
32863166
Citation
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.
Results Reference
background
PubMed Identifier
33288875
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. 2021 Aug;90(2):315-327. doi: 10.1038/s41390-020-01298-1. Epub 2020 Dec 7.
Results Reference
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Comparison Of Outcome Of Lactose Free Formula Milk With Yogurt In Children With Acute Diarrhea

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