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Glycine-based oral rehydration solution: reassessment of safety and efficacy
Insights
Glycine-based oral rehydration solution (ORS) showed no benefit over standard ORS for infant gastroenteritis. Some hospitalized infants receiving glycine-ORS developed hypernatremia, indicating a need for caution.
Area of Science:
- Pediatrics
- Gastroenterology
- Clinical Trials
Background:
- Acute gastroenteritis is a common cause of dehydration in infants.
- Oral rehydration solutions (ORS) are the standard treatment for dehydration.
- Glycine is an amino acid that has been explored as an additive to ORS.
Purpose of the Study:
- To evaluate the safety and efficacy of a glycine-based ORS compared to standard ORS in infants with acute gastroenteritis.
- To determine if glycine-ORS offers therapeutic advantages over standard ORS.
Main Methods:
- A randomized, double-blind trial was conducted in US infants (under 15 months) with acute gastroenteritis.
- Participants were treated as either inpatients or outpatients.
- Comparison was made between glycine-ORS and standard ORS without glycine.
Main Results:
- Therapeutic response (stool volume, illness duration) was similar between groups for both inpatients and outpatients.
- Hypernatremia developed in 13% of hospitalized infants receiving glycine-ORS, compared to none receiving standard ORS (P < 0.04).
- No significant differences were observed among the 77 outpatients.
Conclusions:
- Glycine-ORS did not demonstrate a therapeutic advantage over standard ORS for infant gastroenteritis.
- The development of hypernatremia in some patients receiving glycine-ORS suggests potential safety concerns.
- Further safety studies are recommended before widespread use of glycine-based ORS.
Abstract:
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.