Abstract
Introduction: Lactoferrin (LF) and lysozyme (LZ) have a wide spectrum of antimicrobial activity. Addition of human recombinant LF and LZ to an ORS may have a beneficial effect on diarrhea. Objective. To compare efficacy of glucose (WHO) and rice based ORS with rice based ORS containing recombinant human LF and recombinant human LZ in acute diarrhea in children. Methods: Randomized controlled trial in 140 boys aged 3 -36 months with acute diarrhea and dehydration admitted to the Oral Rehydration Unit (ORU) of IESN in Lima, and Belen Hospital, in Trujillo, Peru. At entry children were randomly assigned to 1) glucose ORS (OMS), b) rice-based ORS or, c) rice based ORS plus LF and LZ. Intake and output were monitored for 48 hours in the ORU, with home and clinic follow up for 12 days. Results: Intention to treat analysis of the combined control treatments versus LF and LZ group showed a decrease in duration (5.21 versus 3.67 days, p=0.05) and increase in the number of children who achieved 48 hours with solid stool, 69.2% versus 85.1% (p< 0.05). There was a non-significant decrease in volume, and in the percent of children who had a new diarrhea episode in the treatment group. Overall intake of ORS was 1910 mL in the treatment group versus 2162 mL in the control groups (p=0.18). No child required intravenous rehydration or developed persistent diarrhea. Conclusion: This study demonstrated the efficacy of the addition of recombinant human LF and LZ to a rice-based ORS in acute diarrhea in children.
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