M. Aloi , F. Pofi, C. Tolone, M. Piccirillo , A. Nicolai , G. Romano, G. D’Arcangelo, S. Cucchiara.
Oral rehydration therapy is the only treatment recommended by the World Health Organization in acute diarrhea in children. The aim of this study was to compare the efficacy and safety of a therapy with gelatin tannate plus oral rehydration versus oral rehydration alone in children with acute gastroenteritis.
Prospective, randomized, open and parallel study performed in two Pediatric Services of tertiary referral hospitals. The study included 60 patients, ages 3–36 months (mean 21.9 ± 12.3), with acute gastroenteritis: 29 received an oral rehydration solution (OR), 31 an oral rehydration solution plus gelatin tannate (OR + G). The primary outcomes evaluated were: the number of bowel movements after 48 and 72 h after initiating treatments. Secondary outcomes were: duration of diarrhea (days), stool characteristics and adverse events. Other clinical variables, as weight, fever, vomiting, appetite and the acceptability of the two treatments were also recorded.
The treatment groups were comparable in terms of age, duration of diarrhea, number of stools and concomitant symptoms. No significant difference was found in the number of bowel movements between the 2 groups 48 h after initiating treatment (2.6 ± 1.7 in the OR + G group vs 3.2 ± 2.2 in the OR group; p = 0.29), although OR + G group showed a significant improvement of stool consistency (p: 0.02). At 72 h a significant reduction of bowel movements was reported in the OR + G group compared to oral rehydration only (1.07 ± 1.3 vs. 2.05 ± 1.7; p = 0.01). No significant differences were found in the average duration of gastroenteritis (4.5 ± 0.9 days in the OR group, 3.0 ± 0.8 days in the OR + G group; p = 0.14). No adverse events were reported in the two groups. Tolerability was good in both groups of patients.
In our study, gelatin tannate used as adjuvant therapy to oral rehydration solution in infants and children with acute diarrhea was associated with a significant decrease in the number of stools at 72 h with an early improvement in the consistency of stools. The safety and tolerance of the study drug were good.
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