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

Authors

1 Dietary Supplements and Probiotic Research Center, Alborz University of Medical Sciences, Karaj, Iran.

2 Department of Pediatrics, Alborz University of Medical Sciences, Karaj, Iran.

3 Department of Medical Emergency, Qom University of Medical Sciences, Qom, Iran.

4 Social Determinants of Health Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.

5 Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.

6 Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran AND Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.

Abstract

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.

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