Effectiveness of GASTROFIX on Duration of Diarrhea and Length of Hospitalization in Children with Acute Gastroenteritis: A Randomized Controlled Trial

Background: According to evidence, the main treatment plans for children with gastroenteritis include the use of an oral solution or intravenous infusion for hydration, continued nutrition; zinc supplementation. The aim of this study was to investigate the effectiveness of Gastro-Fix (registered nutritional supplement) versus placebo on length of hospitalization and duration of diarrhea in children with acute gastroenteritis. Materials and Methods: We conducted a double blind randomized placebo-controlled trial in children with acute gastroenteritis (age between 6 and 120 months). Three hundred eligible patients randomly allocated to one of two parallel groups, Intervention received Gastro-Fix, whereas the placebo group received baby food (cereal based on skimmed milk and wheat without mineral) for a total of 6 days. Gastro-Fix and baby food was administered as a same sachet that could be opened and mixed in water. The primary outcome was length of hospitalization and duration of diarrhea. Results: The Mean length of hospitalization in Gastro-Fix and placebo was 3.43+ 0.57 and 4.70+0.59 day respectively (P<0.001). Median duration of diarrhea was 3 days (range: 3-5, IQR: 3–4 days) in the Gastro-Fix group and 5 days (range 3-6, interquartile range [IQR]: 4–5 days) in the placebo group which was statistically significant (P<0.001). The highest efficacy (diarrhea-free percentage of children) of the Gastro-Fix was observed at day 4 (relative risk [RR]: 0.28; 95% confidence interval [CI]: 0.23-0.35), and at day 5 (RR 0.08; 95% CI: 0.03-0.17) after the intervention. Conclusion: Finding of this study showed that Gastro-Fix can be effective in reducing duration of diarrhea and length of hospitalization in children with diarrhea. This product is suggested to be used in children with acute gastroenteritis.