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

NCT05634603 — Not applicable, Unknown, 66 participants, The Women and Children Hospital of An Giang

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

Registry	NCT05634603
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	66 (Estimated)
Sponsor	The Women and Children Hospital of An Giang (Other); collaborators: Can Tho University of Medicine and Pharmacy
Conditions	Acute Gastroenteritis
Interventions	Lactose-free milk formula (Frisolac LF ®) (Dietary supplement)
Dates	start 2022-12-01 (estimated), primary completion 2024-12-01 (estimated), completion 2025-04-30 (estimated), first posted 2022-12-02, last updated 2022-12-02
Locations	1 site in Vietnam

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Intervention	Active comparator	Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)	Lactose-free milk formula (Frisolac LF ®)
Placebo	Placebo comparator	Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)	Regular infant milk formula

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

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 outcomes

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

+Eligibility

Sex: All, ages: 2 Months to 24 Months

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

+Locations (1)

Facility	City	Country	Status
Can Tho Children Hospital	Can Tho	Vietnam	Recruiting

+Publications

Results publication: 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. PMID 24173771
Results publication: 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. PMID 15279342