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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Gastroenteritis
• Intervention / Treatment: Dietary supplement: Lactose-free milk formula (Frisolac LF ®)

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Can Tho, Vietnam, 0292
    • Recruiting
    • Can Tho Children Hospital
    • Contact: Diep Ngoc Thai, doctor; Phone Number: 084 0775838622; Email: ngocdiepthai41@gmail.com
    • Contact: Rang Ngoc Nguyen, Ph D; Phone Number: 084 0913106404; Email: nguyenngocrang@gmail.com
    • Sub-Investigator: Diep Ngoc Thai, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in diarrhea duration	llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools)	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight gain	7 days
Severity of diarrhea according to the modified Vesikari score	7 days

Collaborators and Investigators

• Sponsor: The Women and Children Hospital of An Giang
• Collaborators: Can Tho University of Medicine and Pharmacy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): April 30, 2025

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: diarrhea lactose-free diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: WCHAnGiang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No