Functional Dyspepsia Investigation for Gut Abnormalities and evaluation of Efficacy, Safety and Time-bound control study with a proprietary blend consisting of clinically proven synergistic poly-botanical extract and Bifidobacterium Infantis (DIGEST Study)

Abstract

Background: To evaluate the efficacy, safety, and quality of life with a proprietary blend of Herbagut & Bifidobacterium longum in patients with functional dyspepsia and recurrent gut abnormalities (DIGEST study).Methods: In a current Post-marketing Phase IV stud y, 131 patients with functional dyspepsia were included. All the patients were treated with a proprietary blend consisting of Herbagut & Bifidobacterium longum (Digespur ®, Nutragenix Healthcare Ltd.) once daily for 28 days. The efficacy of proprietary blend was assessed by evaluating the changes in epigastric pain, early satiety, acidic regurgitation/heartburn, loss of appetite, and retrosternal discomfort. Results: All participants completed the 28-day trial, with no adverse events reported during the study. During the study, treatment with marketed preparation demonstrated significant (p<0.05) improvement in symptoms such as epigastric pain, regurgitation, retrosternal discomfort, sickness, and loss of appetite from the baseline. Furthermore, the proprietary blend also showed improvement in early satiety, nausea and vomiting in functional dyspepsia patients.Conclusion: Treatment with a proprietary blend (Digespur ®) for 28 days showed improvement in several gastrointestinal symptoms and overall quality of life. More research with larger sample sizes and diverse clinical and cultural populations is needed.