Objective: To compare glucose and rice-based oral rehydration solution with rice-based oral rehydration solution containing recombinant human lactoferrin and recombinant human lysozyme in diarrhea outcomes.
Patients and Methods: We conducted a randomized, double-blind controlled trial in children with acute diarrhea and dehydration. One hundred and forty children 5 to 33 months old were block randomized to receive low osmolarity WHO-ORS (G-ORS), rice-based ORS (R-ORS), or rice-based ORS plus lactoferrin and lysozyme (Lf/Lz-R-ORS). Intake and output were monitored for 48 h in the ORU, with continued monitoring through home and clinic follow-up for 14 d.
Results: The G-ORS and R-ORS groups did not show any differences in diarrhea outcomes and were therefore combined as the control group. Intent-to-treat analysis showed a significant decrease in duration of diarrhea (3.67 d vs 5.21 d, P = 0.05) in the Lf/Lz-R-ORS group as compared with the control group and a significant increase in the number of children who achieved 48 h with solid stool, 85% vs 69% (P < 0.05). There were also decreases in volume of diarrhea and the percentage of children who had a new diarrhea episode after achieving the endpoint.
Conclusions: Addition of recombinant human lactoferrin and lysozyme to a rice-based oral rehydration solution had beneficial effects on children with acute diarrhea.
*Instituto de Investigación Nutricional, Lima, Peru
†Instituto Especializado de Salud del Niño, Lima
‡Hospital Belén, Trujillo, Peru
§Department of Nutrition, University of California, Davis
Received 25 May, 2006
Accepted 18 October, 2006
Address correspondence and reprint requests to Nelly Zavaleta, MD, Instituto de Investigación Nutricional (IIN), Av. La Molina 1885, La Molina, Lima 12, Peru (e-mail: email@example.com).
N.Z. developed the concept for the study and study design, and participated in the execution of the study, analysis, interpretation, and preparation of the manuscript. D.F. supervised clinical aspects of the project and contributed to the study design and preparation of the manuscript. J.R. supervised clinical aspects of the project and contributed to the study design and preparation of the manuscript. J.S. was responsible for medical care of the children and contributed to the preparation of the manuscript. S.A. was responsible for medical care of the children and contributed to the preparation of the manuscript. B.L. helped develop the concept for the study and study design, interpretation, and preparation of the manuscript.
This study was supported by Ventria Bioscience, Sacramento, CA.