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.