Abstract
Studies have demonstrated efficacy of rice-ORS in treatment of acute and persistent diarrhea. Lactoferrin (LF) and lysozyme (LZ) have antimicrobial activity against a wide spectrum of bacteria, viruses, parasites and fungi. Addition of human LF and LZ to ORS may result in a reduced duration of diarrhea and enhanced rate of recovery. We compared glucose and rice based ORS with rice based ORS with recombinant human LF and LZ in diarrhea outcomes in a prospective, double-blind, randomized controlled trial in 3–36 mo boys (n=140) with acute diarrhea and dehydration admitted to the Oral Rehydration Unit (ORU). At entry children were randomly assigned to a) low osmolarity WHO ORS, b) rice-based ORS or c) rice based ORS plus LF and LZ. Intake and output were monitored for 48 h in the ORU, with home and clinic follow up for 12 d. Intention to treat analysis of the combined control treatments vs recombinant LF and LZ showed a decrease in duration (3.67 vs 5.21 d, p=0.05) and increase in number of children who achieved 48 h with solid stool, 85.1% vs 69.2% (p< 0.05). There was a non-significant decrease in volume (66.4 ml/kg BW vs 80.0, p=0.24) and children who had a new diarrhea episode was 18.7% compared to 8.5% in the treatment group (p=0.11). Overall intake of ORS was 1910 mL in the treatment group vs 2162 mL in control groups (p=0.18). No child required IV intervention due to dehydration or developed persistent diarrhea. This study demonstrates beneficial effects of addition of recombinant human LF and LZ to a rice-based ORS on acute diarrhea in children. Supported by Ventria Bioscience.
Published Version
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