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

NCT05634603 | Unknown

• 1 other identifier: WCHAnGiang
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Gastroenteritis

Keywords

diarrhea lactose-free diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Weight gain

  7 days

• Severity of diarrhea according to the modified Vesikari score

  7 days

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Lactose-free milk formula (Frisolac LF ®)

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

Placebo

PLACEBO COMPARATOR

Regular infant milk formula

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

Interventions

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

Intervention; Placebo

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 2- 24 months old on artificial milk formula
• Acute diarrhea (3 or more loose or liquid stools per day)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Women and Children Hospital of An Giang: lead
• Can Tho University of Medicine and Pharmacy: collaborator

Study Sites (1)

Can Tho Children Hospital

Can Tho, 0292, Vietnam

RECRUITING

Related Publications (2)

• 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 RESULT

• 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 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Medicine and Pharmacy of Can Tho

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 2, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: April 30, 2025
• Last Updated: December 2, 2022

Record last verified: 2022-11

Locations

VN (1)