A double-blind controlled clinical trial on the efficacy and safety of the use of L-alanine oral rehydration solution (ORS) in the management of acute diarrhea in children

The addition of a neutral amino acid like l-alanine to an ORS has been found to enhance sodium and water reabsorption. A double-blind randomized trial was conducted to determine the efficacy and safety of using an ORS containing 90 mmol/L of l-alanine and 90 mmol/L of glucose as compared to the standard WHO-ORS in the management of acute diarrhea in children. Included were 140 male patients, 3-36 months, with a history of 3 or more watery stools in the past 24 hours of not more than 5 days, with signs of moderate to severe dehydration and with weight for length /_ 70% of NCHS standards. Rehydration was done following WHO recommendations using either the standard or l-alanine ORS. Feedings, in the form of breastmilk, formula and/or semi-solids were resumed thereafter. Stools were replaced by volume with ORS until diarrhea ceased. The clinical and laboratory characteristics of the 2 groups, 70 each, were comparable before intervention. Mean diarrheal duration was similar in both groups after intervention (71 +/_ 50 vs 60 +/_ 31 hours in the l-alanine ORS and WHO-ORS groups respectively). No difference was observed between the two formulations for all other variables except the mean urine output on the 6th-24th hours (40 vs. 31 ml/kg body weight/day, p = 0.05) which was greater in the l-alanine group. Further studies among infants and children have to be conducted to determine the optimal osmolality of the solution and amino acid and glucose concentration.

Clinical trial on the efficacy and safety of added glycine and glucyl glycine to oral rehydration solution

This study was undertaken to determine the efficacy and safety of using an ORS with added glycine and glycyl-glycine. This was a double blind, controlled clinical trial. Randomization was done using permuted blocks of variables lenghts. The code was entrusted to personnel not connected with the research and obtained only after submission of observations. The patients were allocated to receive either the standard WHO-ORS formulation or the ORS-glycine and glycyl-glycine formulation. Addition of glycine and glycyl-glycine did not offer beneficial effects in terms of reduction of stool volume and duration of diarrhea. The absorption-promoting quality of the glycine and glycyl-glycine added to the ORS was observed by the higher weight gain after rehydration, 24 hours and, on discharge, despite a higher stool output. This property was offset by the consequent osmotic penalty