(OR18-02-26) Amino Acid-Fortified Oral Rehydration Therapy Reduces the Duration of Pediatric Diarrhea

Objectives: The objective of this study was to evaluate the effect of an amino-acid fortified Oral Rehydration Therapy (ORT) on the duration of pediatric acute infectious diarrhea. We hypothesized that the amino acid-fortified ORT (FORT) would decrease the duration of diarrhea in pediatric patients in comparison the standard of care, glucose-based ORT.

Methods: This was a double-blind, randomized, controlled clinical trial in pediatric patients (6 - 60 months old) with acute infectious diarrhea. Patients were recruited from three Rutgers-Robert Wood Johnson locations in New Jersey and randomly assigned to the standard of care Oral Rehydration Therapy or the experimental intervention Fortified Oral Rehydration Therapy (FORT), which contains five amino acids and reduced glucose. Patients were treated with their prescribed intervention following World Health Organization Plan A for prevention of dehydration and their duration of diarrhea was measured. Stool samples were collected throughout the duration of the illness and fecal antimicrobial peptide beta-defensin-2 and immune antibody secretory Immunoglobulin A were quantified.

Results: 59 children were enrolled in the FORTified Kids Study from June 2024 to February 2026. 45 children and their caregivers completed all study activities per protocol. A per protocol analysis of the entire study population revealed that the diarrheal duration from treatment start to last diarrheal stool in children who received FORT was approximately 25 hours less than the children who received ORT, but this difference was trending toward significance (p = 0.08). When analyzed by sex, female children treated with FORT had a significantly shorter diarrheal duration than female children treated with ORT (p < 0.05), but there was no significant differences in male children treated with FORT or ORT. Stool sample analysis for beta-defensin-2 and secretory IgA did not show any differences between groups. There were no adverse events in either group.

Conclusions: This randomized clinical trial provides evidence that an amino acid-based formulation of Oral Rehydration Therapy may be superior to the standard of care glucose-based oral rehydration in children with mild to moderate diarrhea, particularly female children. Further research is necessary.

Funding Sources: This study was funded by The Gerber Foundation.