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Safety and efficacy of rice‐based ORS containing recombinant human lactoferrin and lysozyme in Peruvian children with diarrhea
Author(s) -
Zavaleta Nelly,
Figueroa Dante,
Rivera Juan,
Sanchez Julia,
Segundo Alfaro,
Lonnerdal Bo
Publication year - 2006
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.20.4.a571-b
Subject(s) - diarrhea , medicine , lysozyme , lactoferrin , acute diarrhea , placebo , recombinant dna , gastroenterology , biology , biochemistry , gene , genetics , alternative medicine , pathology
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.