Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants

Sponsor

The Women and Children Hospital of An Giang (Other)

Overall Status

Recruiting

CT.gov ID

NCT05634603

Collaborator

Can Tho University of Medicine and Pharmacy (Other)

Enrollment

Location

Arms

28.9

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Gastroenteritis	Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised Controlled TrialRandomised Controlled Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants: A Randomised Controlled Trial

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Lactose-free milk formula (Frisolac LF ®)	Dietary Supplement: Lactose-free milk formula (Frisolac LF ®) Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula
Placebo Comparator: Placebo Regular infant milk formula	Dietary Supplement: Lactose-free milk formula (Frisolac LF ®) Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula

Arm

Intervention/Treatment

Active Comparator: Intervention

Lactose-free milk formula (Frisolac LF ®)

Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)

Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula

Placebo Comparator: Placebo

Regular infant milk formula

Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)

Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula

Outcome Measures

Primary Outcome Measures

Change in diarrhea duration [7 days]
llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools)

Secondary Outcome Measures

Weight gain [7 days]
Severity of diarrhea according to the modified Vesikari score [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Can Tho Children Hospital	Can Tho		Vietnam	0292

Sponsors and Collaborators

The Women and Children Hospital of An Giang
Can Tho University of Medicine and Pharmacy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rang Nguyen, University of Medicine and Pharmacy of Can Tho, The Women and Children Hospital of An Giang

ClinicalTrials.gov Identifier:

NCT05634603

Other Study ID Numbers:

WCHAnGiang

First Posted:

Dec 2, 2022

Last Update Posted:

Dec 2, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rang Nguyen, University of Medicine and Pharmacy of Can Tho, The Women and Children Hospital of An Giang

diarrhea lactose-free diet

Additional relevant MeSH terms:

Gastroenteritis

Study Results

No Results Posted as of Dec 2, 2022