Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants
Primary Purpose
Acute Gastroenteritis
Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Lactose-free milk formula (Frisolac LF ®)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gastroenteritis focused on measuring diarrhea lactose-free diet
Eligibility Criteria
Inclusion Criteria: Children 2- 24 months old on artificial milk formula Acute diarrhea (3 or more loose or liquid stools per day) Exclusion Criteria: Used antibiotics within 3 days before admission Breastfeeding Severe dehydration, defined by a need of IV rehydration Malnutrition (weight/height< -3SD) Chronic underlying disease, immunocompromised condition or systemic infection
Sites / Locations
- Can Tho Children HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Placebo
Arm Description
Lactose-free milk formula (Frisolac LF ®)
Regular infant milk formula
Outcomes
Primary Outcome Measures
Change in diarrhea duration
llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools)
Secondary Outcome Measures
Weight gain
Severity of diarrhea according to the modified Vesikari score
Full Information
NCT ID
NCT05634603
First Posted
November 21, 2022
Last Updated
November 21, 2022
Sponsor
The Women and Children Hospital of An Giang
Collaborators
Can Tho University of Medicine and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT05634603
Brief Title
Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants
Official Title
Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Women and Children Hospital of An Giang
Collaborators
Can Tho University of Medicine and Pharmacy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether lactose-free milk will change diarrhea duration and severity in formula-fed infants with acute gastroenteritis presenting to pediatric wards.
Detailed Description
More than 525 000 children die each year due to diarrheal disease, the second leading cause of death among children under five. Children from Asian countries, including Vietnamese children, frequently have lactose intolerance. In addition, gastroenteritis, specifically rotavirus-induced gastroenteritis, temporarily impairs lactase enzymes in the intestines. In a recent Cochrane review of 33 randomized and quasi-randomized trials, lactose-free diets reduced diarrhea among children younger than 5 years old. These trials, however, involved inpatients in middle-or high-income countries. Neither patient was from a developing country, where diarrheal diseases often cause significant morbidity and mortality. The purpose of this study is to determine whether lactose-free milk will change the duration and severity of diarrhea in Vietnamese infants with acute gastroenteritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastroenteritis
Keywords
diarrhea lactose-free diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Lactose-free milk formula (Frisolac LF ®)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Regular infant milk formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactose-free milk formula (Frisolac LF ®)
Intervention Description
Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula
Primary Outcome Measure Information:
Title
Change in diarrhea duration
Description
llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Weight gain
Time Frame
7 days
Title
Severity of diarrhea according to the modified Vesikari score
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children 2- 24 months old on artificial milk formula
Acute diarrhea (3 or more loose or liquid stools per day)
Exclusion Criteria:
Used antibiotics within 3 days before admission
Breastfeeding
Severe dehydration, defined by a need of IV rehydration
Malnutrition (weight/height< -3SD)
Chronic underlying disease, immunocompromised condition or systemic infection
Facility Information:
Facility Name
Can Tho Children Hospital
City
Can Tho
ZIP/Postal Code
0292
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diep Ngoc Thai, doctor
Phone
0775838622
Ext
084
Email
ngocdiepthai41@gmail.com
First Name & Middle Initial & Last Name & Degree
Rang Ngoc Nguyen, Ph D
Phone
0913106404
Ext
084
Email
nguyenngocrang@gmail.com
First Name & Middle Initial & Last Name & Degree
Diep Ngoc Thai, doctor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24173771
Citation
MacGillivray S, Fahey T, McGuire W. Lactose avoidance for young children with acute diarrhoea. Cochrane Database Syst Rev. 2013 Oct 31;2013(10):CD005433. doi: 10.1002/14651858.CD005433.pub2.
Results Reference
result
PubMed Identifier
15279342
Citation
Simakachorn N, Tongpenyai Y, Tongtan O, Varavithya W. Randomized, double-blind clinical trial of a lactose-free and a lactose-containing formula in dietary management of acute childhood diarrhea. J Med Assoc Thai. 2004 Jun;87(6):641-9.
Results Reference
result
Learn more about this trial
Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants
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