P3.J186: Clinical efficacy and safety of a novel amino acid-based, non-glucose oral rehydration solution in children 1-5 years of age with mild or moderate dehydration: an open-label RCT

Background: Greater net fluid absorption had been demonstrated in adults using a novel amino acid (AA)-based, non-glucose oral rehydration solution (ORS) vs traditional glucose-containing ORS. The current study objective was to demonstrate efficacy and safety of a novel AA-ORS in children 1-5 years of age (y).

Methods: In this multi-center, open-label, controlled prospective study (ClinicalTrials.gov ID NCT05247879; IRB Approval, Thailand CREC: COA-CREC034/2022), eligible children 1-5y in Thailand who were hospitalized with mild to moderate dehydration due to acute diarrhea were randomized to receive: medical standard of care ORS (blend of glucose and electrolytes; Control-ORS) or a novel ORS that had a glucose-free blend of AA and electrolytes (AA-ORS) over a 12 hour (h) period; after 12 h, all participants received Control-ORS or other fluids per standard-of-care if needed. Hydration was assessed at 4, 8, 12, 18, and 24h. Achievement of clinically assessed adequate rehydration without need for IV fluids was the primary outcome measure. Secondary outcomes included weight recovery, tolerance, and liquid stool resolution.

Results: A total of 60 participants were enrolled (AA-ORS, n=31; Control-ORS, n=29). Median age was 3.0 y (range: 1-5 y) and mean (SD) weight was 14.3 kg (3.7 kg). At baseline, 57 participants (95.0%) had mild dehydration and 3 (5.0%) had moderate dehydration. Four (6.7%) were withdrawn for reasons unrelated to study ORS. In the AA-ORS and Control-ORS groups, respectively, clinically assessed successful oral rehydration (Table) was achieved at 12 h by 74.2% and 72.4% (P>0.999) and at 24 h by 90.3% and 96.6% (P=0.613) of participants. Use of AA-ORS was well-tolerated. No group differences were detected in weight recovery, comfort or parent satisfaction, or resolution or time to resolution of liquid stool. No adverse events related to study product were reported.

Conclusion: A novel amino acid (AA)-based, non-glucose ORS was well-tolerated and demonstrated effective rehydration by 24 h in children 1-5 years of age who had mild to moderate dehydration. AA-ORS was comparable to medical standard-of-care ORS for rehydration of children with dehydration due to diarrhea.