Clinical outcomes of two lactose-free formulas in the management of acute childhood diarrhea

doi:10.5409/wjcp.v15.i1.114953

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World Journal of Clinical Pediatrics

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Randomized Controlled Trial

©Author(s) (or their employer(s)) 2026. No commercial re-use. See Permissions. Published by Baishideng Publishing Group Inc.

World J Clin Pediatr. Mar 9, 2026; 15(1): 114953
Published online Mar 9, 2026. doi: 10.5409/wjcp.v15.i1.114953

Clinical outcomes of two lactose-free formulas in the management of acute childhood diarrhea

Nopaorn Phavichitr, Ruangvith Tantibhaedhyangkul, Termpong Dumrisilp, Sittichoke Prachuapthunyachart, Wilaiporn Chanpreecha, Panjachat Ratanamongkol, Voranush Chongsrisawat

Nopaorn Phavichitr, Ruangvith Tantibhaedhyangkul, Wilaiporn Chanpreecha, Department of Pediatrics, Phramongkutklao Hospital, Bangkok 10400, Thailand

Termpong Dumrisilp, Panjachat Ratanamongkol, Department of Pediatrics, Bhumibol Adulyadej Hospital, Bangkok 10220, Thailand

Sittichoke Prachuapthunyachart, Voranush Chongsrisawat, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand

Author contributions: Phavichitr N, Chongsrisawat V, and Tantibhaedhyangkul R contributed to the conceptualization of the study, the visualization of the results, and the original draft of the manuscript; Phavichitr N, Chongsrisawat V, Tantibhaedhyangkul R, and Dumrisilp T contributed to data curation; Phavichitr N, Chongsrisawat V, Tantibhaedhyangkul R, Dumrisilp T, Prachuapthunyachart S, and Chanpreecha W contributed to the methodological framework; Phavichitr N, Chongsrisawat V, Dumrisilp T, and Ratanamongkol P contributed to project administration; Phavichitr N, Chongsrisawat V, Tantibhaedhyangkul R, and Prachuapthunyachart S contributed to editing processes. All authors read and approved the final manuscript.

Institutional review board statement: This study was reviewed and approved by the local Ethical Review Board, No. 0361/66.

Clinical trial registration statement: This study has been registered at https://www.thaiclinicaltrials.org/show/TCTR20240706013 (No. TCTR20240706013).

Informed consent statement: All the individuals who participated in this study provided their written informed consent prior to study enrollment.

Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.

CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.

Data sharing statement: No additional data are available.

Corresponding author: Voranush Chongsrisawat, MD, Professor, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, 1873, Rama 4 Road, Pathumwan, Bangkok 10330, Thailand. voranush.c@chula.ac.th

Received: October 11, 2025
Revised: November 13, 2025
Accepted: January 5, 2026
Published online: March 9, 2026
Processing time: 155 Days and 4.2 Hours

Abstract

BACKGROUND

Acute diarrhea is the most common gastrointestinal disease in children under five years of age and is associated with significant morbidity and mortality risks. Lactose-free formulas may be beneficial for hospitalized patients.

AIM

To compare the efficacy, safety, and cost-effectiveness of a medium-chain triglyceride-containing lactose-free formula (MLF) with a standard lactose-free formula (SLF) in children hospitalized with acute diarrhea.

METHODS

In this randomized, double-blind, controlled trial, children aged 6-24 months were randomized to receive MLF or SLF. The primary outcomes were the duration until diarrhea resolution and the frequency of stools after enrollment. Secondary outcomes included length of hospital stay, treatment costs, and caregiver satisfaction.

RESULTS

Forty-four children completed the study (MLF = 22, SLF = 22). The median duration of diarrhea after enrollment did not differ significantly between the groups, 24.0 hours [interquartile range (IQR): 21.5] vs 45.0 hours (IQR: 49.0); P = 0.293. The reduction in stool frequency was also comparable [7.5 (IQR: 5.8) vs 4.0 (IQR: 3.8) times/day; P = 0.083]. The Hodges-Lehmann estimated median difference in diarrhea duration was -4 hours (95% confidence interval: -26.0 to 2.0), supporting the noninferiority of MLF. The median length of hospital stay was 2 days in both groups. Formula costs were significantly lower in the MLF group (227.9 Thai Baht vs 373.6 Thai Baht; P < 0.001). Caregiver satisfaction, product acceptance, and safety profiles were comparable between the groups.

CONCLUSION

MLF demonstrated noninferior clinical outcomes and safety compared to SLF, with a significant reduction in formula-related costs. MLF could be an appropriate alternative for the management of acute diarrhea in young children, especially in resource-constrained settings.

Keywords: Acute diarrhea; Acute gastroenteritis; Children; Lactose-free formula; Nutritional management

Core Tip: This randomized controlled trial compared a medium-chain triglyceride-containing lactose-free formula (MLF) with a standard lactose-free formula in children hospitalized with acute diarrhea. MLF showed noninferior efficacy and safety compared to standard lactose-free formula, with similar clinical outcomes and caregiver satisfaction, but at significantly lower cost. MLF may therefore serve as a cost-effective alternative for managing acute diarrhea in young children, particularly in resource-limited settings.