COMPOSITION AND PRELIMINARY EVALUATION OF A HYDROLYZED RICE-BASED ORAL REHYDRATION SOLUTION FOR THE TREATMENT OF ACUTE DIARRHEA IN CHILDREN

Objective: The purpose of this study was to experimentally develop and clinically evaluate the safety and potential usefulness of a rice-bas ed, short glucose polymer oral rehydration solution (ORS), Amylyte(TM) , in the treatment of acute diarrhea. Amylyte(TM) has a similar osmola lity but a higher caloric density than the WHO ORS. Methods: Different amounts of rice were cooked in 500 mi of water containing salts (1.5 g NaCl, 600 mg KCl, and 150 mg CaCl2 with varying amounts of thermophi lic amylase (252,500 modified Wohlgemuth units). Amylase (25 mg) thinn ed the gluey rice water when 100 g of rice was cooked in 500 mi of wat er for 10 minutes. The volume of the resultant supernatant (Amylyte(TM )') was approximately 250 mi. A two-part, clinical case study was perf ormed. In study 1, 12 children with diarrhea and mild dehydration were studied to determine the safety of Amylyte(TM). In study 2, Amylyte(T M) and the WHO ORS were given to 24 and 31 male children with acute di arrhea and moderate to severe dehydration, respectively. Results: 92-9 6% of the rice amylose and amylopectin were converted to short polymer s of glucose (3-9 molecules of glucose). The osmolality of 7,994 packa ges used to make the Amylyte solution ranged between 277-340 mOsm/kg. The mean electrolyte composition was Na+ = 68 mEq/L, K+ = 20 mEq/L, Cl = 73 mEq/L, the caloric density 425 kcal/L and rice proteins 0.7 g/L. In study 1, 12 children with diarrhea and mild dehydration were rehyd rated successfully with Amylyte ORS and the diarrhea ceased within 48 hours. None developed clinical features of carbohydrate intolerance. I n study 2, an open-label clinical case study, children with acute diar rhea given Amylyte ORS had significantly less stool output than childr en given the WHO ORS. Conclusions: Amylyte(TM) ORS has the advantages of a higher caloric density than the WHO ORS and shares a simple prepa ration of appropriate osmolality and electrolyte composition. It can s afely and effectively rehydrate children with acute diarrhea and dehyd ration.