Glycine-based oral rehydration solution: reassessment of safety and efficacy.

We evaluated the safety and efficacy of a glycine-based orally administered rehydration solution by comparing it with a standard oral rehydration solution (ORS) without glycine in a randomized double-blind trial in United States infants (age less than 15 months) given treatment for acute gastroenteritis as inpatients or outpatients. The response to therapy (stool volume and duration of illness) was similar in the two groups, except that in four (13%) of 31 hospitalized infants receiving glycine-ORS hypernatremia developed, (one had symptoms) compared with none of 35 receiving ORS (P less than 0.04). Among the 77 outpatients there were no differences between the groups. This study demonstrates that glycine-ORS did not provide any therapeutic advantage over standard ORS, and hypernatremia developed in some patients receiving glycine-ORS. We suggest that caution be used with this type of solution until further safety studies have been done.