The effect of gelatin tannate in acute diarrhea in children.

ESPGHAN 50th Annual Meeting – Abstracts. May 2017. Pag 114

Objectives and study:

Acute gastroenteritis (AGE) is a common cause of morbidity and mortality worldwide. The management of children and infants with viral AGE mainly depends on oral or intravenous hydration, breastfeeding, and early refeeding. Probiotics are also beneficial. Gelatin tannate (GT) is a nonabsorbable antidiarrheal agent investigated in few clinical studies. The aim of this study was to investigate the effects of GT on children with viral AGE.

Methods:

This randomized, placebo-controlled, prospective study involved children aged from six months to 10 years with acute diarrhea. After assessment all patients including anthropometric measurements, physical examination, and Modified Vesikari and CDS scores, children not complying with the study protocol or with diarrhea with a known non-viral etiology were excluded. Patients were randomized on the basis of order of presentation. The patient and his/her parents were blinded to the treatment drug. The study group received GT (250 mg sachet) four times a day plus oral rehydration solution (ORS) plus peroral zinc (15 mg/day) for five days. The control group received identical appearing maltodextrin containing placebo sachets four times a day plus ORS plus peroral zinc for five days. Stool frequency and numbers of patients with diarrhea in each group were compared at 12, 24, 48, 72, 96, and 120 hours. Duration of diarrhea and weight changes after 120 hours was recorded.

Results:

Seventy one children were included in the study group, while 73 children were included in the control group. The groups were not different in terms of age, anthropometric measurements, admission Vesikari and CDS scores, numbers of diarrhea and vomiting episodes during the previous 24 hours, or duration of diarrhea until admission. Mean stool frequency was lower in the study group at 0-12 hours (3±1.8 vs. 3.6±1.9, p=0.04). The study group exhibited more weight gain after 120 hours of treatment and shorter total duration of diarrhea, although the difference was not statistically significant. Fewer patients in the study group had diarrhea at the end of 12, 24, 96, and 120 hours. Patients treated with GT with Bristol scores of 7 at admission exhibited more weight gain than patients with Bristol scores of 6 (296±38 vs. 137±39, p=0.04). Rotavirus was the mostly determined etiological agent in the study, and like other etiologies, GT improves diarrhea better, but not statistically significant, than placebo in children with rotavirus. No adverse events were recorded in any patients.

Conclusion:

GT resulted in a decreased stool frequency at 12 hours in children with viral gastroenteritis. It shortened total duration of diarrhea and resulted in more weight gain compared to placebo in children with AGE.