A natural plant fiber for gut inflammatory diseases: A randomized, double-blind, parallel group, reference controlled study

Abstract

Background: Recent studies indicate that imbalanced gut microbiota and gut inflammation lead to various gut-related disorders. Natural dietary supplementation is a complementary approach to address gut inflammation and gut-related disorders. In this context, Consolax®developed, a patent-filed innovative plant fiber formula with prebiotic, antioxidant, anti-inflammatory, and immunomodulatory properties. This study aimed to assess the efficacy and safety of Consolax® on gut health/inflammation among human subjects with imbalanced gut microbiota, gut inflammation, and inflammatory bowel syndrome. Methods: We conducted a randomized, double-blind, parallel reference-controlled study among 24 of 29 subjects screened for the Rome IV Diagnostic Criteria for functional inflammatory disease, predominantly irritable bowel syndrome. The subjects were randomized into the test and reference groups (each, n=12). The test group underwent supplementation with Consolax® powder 5 g daily (b.i.d.) and the reference group received the reference product (psyllium husk powder) at the same dose of 5 g daily (b.i.d.). Both supplements were administered orally for 30 days along with standard care. Efficacy and safety outcomes were evaluated at four different time intervals, days 7+2 (visit 1), 14+2 (visit 2), 21+2 (visit 3), and 30+2 (visit 4). Results: Consolax® supplementation lowered abdominal pain (based on the Visual Analog Scale) within the treatment groups during visits 3 and 4 compared to the baseline. Beneficial bacterial levels increased (p<0.0139) among Consolax®-supplemented subjects during visit 4 and pathogenic bacterial levels (p<0.004) decreased within and between the groups. The test group showed increased stool consistency (p<0.0005) and significantly improved (p<0.0005) spontaneous complete bowel movement during visit 4. The study results further underlie the anti-inflammatory properties of the test product which reflected in decreased inflammatory marker levels. Conclusion: Consolax® is efficacious with excellent tolerability and safety for patients with imbalanced gut microbiota and in addressing overall gut health issues.