Evalutaion of gelatine tannate agaisnt symtomps of acute diarrhoea in paediatric patients

OBJECTIVES AND STUDY: Acute diarrhoea, with or without vomiting, is a frequent problem in childhood. Mucoprotective agents such as gelatin tannate and xyloglucan help to reestablish normal intestinal function. Besides its mucoprotective activity, additional evidence suggests that gelatin tannate reduce inflammation, prevents growth of some bacterial species, and preserves the intestinal mucous layer. Thus, in line with the need for additional assessment of mucoprotectors, the current single‐centre, randomised, controlled, double‐blind trial was designed to assess the efficacy and safety of gelatin tannate in paediatric patients with acute diarrhoea. METHODS: This randomised, controlled, double‐blind, parallel‐group, single‐centre clinical trial was conducted to determine the efficacy and safety of gelatin tannate plus ORS, compared with ORS plus placebo, in paediatric patients (aged 3 months to 12 years) with infectious or noninfectious acute diarrhoea. RESULTS: A total of 251 eligible patients were enrolled in the trial. 203 patients completed the study (gelatin tannate plus ORS, n=103; ORS alone, n=100). As shown in Figure 1, at all study assessment timepoints from 24 hours onwards, the incidence of nausea was significantly lower in the gelatin tannate‐plus‐ORS group than the ORS group alone (p=0.01). The same was true for abdominal pain (at 24 hours: p=0.02). From 12 hours onwards, the incidence of watery stools was significantly lower in the gelatin tannate than ORS group (p=0.01). Significantly more patients in the combination than ORS‐alone group had dehydration at baseline (p<0.01). Subsequently, no significant difference in the occurrence of dehydration was noted between the two groups, since all patients in both groups were treated with ORS. Nonetheless, from 36 hours onwards, a nonsignificant trend (p=0.05) was evident towards a lower incidence of dehydration in the combination than ORS‐alone group. After 36 and 72 hours' hospitalisation, fever was recorded in significantly fewer patients treated with gelatin tannate plus ORS rather than in the ORS‐alone group (p<0.01). EFFECTS ON STOOL FREQUENCY: As shown in Figure 2, from 12 hours onwards, stool frequency was significantly lower in the gelatin tannate‐plus‐ORS group than in the ORS‐alone group (at 12 hours: p<0.01). At all timepoints during the study, the proportion of patients with SDI improvement, indicating resolution of diarrhea, was significantly greater (p<0.01) in the gelatin tannate‐plus‐ORS group than in the ORS‐alone group (at 12 hours: p<0.01; Figure 3). No adverse events occurred during the trial. CONCLUSION: administration of gelatin tannate in combination with ORS is an effective and safe option for the treatment of acute diarrhoea in the paediatric population.