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

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

Shankaranarayanan Jeyakodi^*1, Arunkanth Krishnakumar¹, Poorna Prasad S², Ashok Godavarthi³

¹Zeus Hygia LifeSciences Pvt. Ltd., Plot No.47, Raviraja Industries, TIE, Balanagar, Hyderabad, Telangana 500037, India; ²Sri Venkateshwara Hospital NH 7, Hosur Rd, Zuzuvadi, Madiwala, 1st Stage, BTM Layout, Bengaluru, Karnataka 560068; ³Radiant Research Services Pvt Ltd No.99/A, 8th Main, 3rd Phase, Peenya Industrial Area, Bangalore-560058, India

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.

Keywords: Consolax, gut microbiota, inflammatory bowel syndrome, constipation, anti-inflammatory

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How to cite this article:

Shankaranarayanan Jeyakodi, Arunkanth Krishnakumar, Poo-rna Prasad S, Ashok Goda-varthi.A natural plant fiber for gut inflammatory diseases: A randomized, double-blind, parallel group, reference controlled study. International Journal of Traditional and Complementary Medicine 2022, 7:44. DOI: 10.28933/ijtcm-2022-02-2005

References:

1. Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol 2021;19:55-71.
2. Santonicola A, Gagliardi M, Guarino MPL, et al. Eating Disorders and Gastrointestinal Diseases. Nutrients 2019;11:3038.
3. Valdes AM, Walter J, Segal E, Spector TD. Role of the gut microbiota in nutrition and health. BMJ 2018;361:k2179.
4. Andrews CN, Sidani S, Marshall JK. Clinical Management of the Microbiome in Irritable Bowel Syndrome. J Can Assoc Gastroenterol 2020;4:36-43.
5. Lo Presti A, Zorzi F, Del Chierico F, et al. Fecal and Mucosal Microbiota Profiling in Irritable Bowel Syndrome and Inflammatory Bowel Disease. Front Microbiol 2019;10:1655.
6. Sperber AD, Bangdiwala SI, Drossman DA, et al. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. Gastroenterology 2021;160:99-114.e3.
7. Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA 2015;313:949-958.
8. El-Salhy M, Hatlebakk JG, Hausken T. Diet in Irritable Bowel Syndrome (IBS): Interaction with Gut Microbiota and Gut Hormones. Nutrients 2019;11:1824.
9. Sakkas H, Bozidis P, Touzios C, et al. Nutritional Status and the Influence of the Vegan Diet on the Gut Microbiota and Human Health. Medicina (Kaunas) 2020;56:88.
10. Zmora N, Suez J, Elinav E. You are what you eat: diet, health and the gut microbiota. Nat Rev Gastroenterol Hepatol 2019;16:35-56.
11. Holscher HD. Dietary fiber and prebiotics and the gastrointestinal microbiota. Gut Microbes 2017;8:172-184.
12. Makki K, Deehan EC, Walter J, Bäckhed F. The Impact of Dietary Fiber on Gut Microbiota in Host Health and Disease. Cell Host Microbe 2018;23:705-715.
13. Slavin JL. Position of the American Dietetic Association: health implications of dietary fiber. J Am Diet Assoc 2008;108:1716-1731.
14. Burns AM, Zitt MA, Rowe CC, et al. Diet quality improves for parents and children when almonds are incorporated into their daily diet: a randomized, crossover study. Nutr Res 2016;36:80-89.
15. Krupa-Kozak U, Drabińska N, Jarocka-Cyrta E. The effect of oligofructose-enriched inulin supplementation on gut microbiota, nutritional status and gastrointestinal symptoms in paediatric coeliac disease patients on a gluten-free diet: study protocol for a pilot randomized controlled trial. Nutr J 2017;16:47.
16. Baer DJ, Stote KS, Henderson T, et al. The metabolizable energy of dietary resistant maltodextrin is variable and alters fecal microbiota composition in adult men. J Nutr 2014;144:1023-1029.
17. Béghin L, Tims S, Roelofs M, et al. Fermented infant formula (with Bifidobacterium breve C50 and Streptococcus thermophilus O65) with prebiotic oligosaccharides is safe and modulates the gut microbiota towards a microbiota closer to that of breastfed infants. Clin Nutr 2021;40:778-787.
18. Bengtsson M, Hammar O, Mandl T, Ohlsson B. Evaluation of gastrointestinal symptoms in different patient groups using the visual analogue scale for irritable bowel syndrome (VAS-IBS). BMC Gastroenterol 2011;11:122.
19. Bengtsson M, Ohlsson B, Ulander K. Development and psychometric testing of the Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS). BMC Gastroenterol 2007;7:16.
20. Ding C, Fan W, Gu L, et al. Outcomes and prognostic factors of fecal microbiota transplantation in patients with slow transit constipation: results from a prospective study with long-term follow-up. Gastroenterol Rep (Oxf) 2018;6:101-107.
21. Rao SSC, Xiang X, Yan Y, et al. Randomised clinical trial: linaclotide vs placebo-a study of bi-directional gut and brain axis. Aliment Pharmacol Ther 2020;51:1332-1341.
22. Zhang X, Tian H, Gu L, et al. Long-term follow-up of the effects of fecal microbiota transplantation in combination with soluble dietary fiber as a therapeutic regimen in slow transit constipation. Sci China Life Sci 2018;61:779-786.
23. He X, Cui LH, Wang XH, et al. Modulation of inflammation by toll-like receptor 4/nuclear factor-kappa B in diarrhea-predominant irritable bowel syndrome. Oncotarget 2017;8:113957-113965.
24. Peng C, Ouyang Y, Lu N, Li N. The NF-κB Signaling Pathway, the Microbiota, and Gastrointestinal Tumorigenesis: Recent Advances. Front Immunol 2020;11:1387.
25. Yang Z, Liu W, Zhou X, et al. The effectiveness and safety of curcumin as a complementary therapy in inflammatory bowel disease: A protocol of systematic review and meta-analysis. Medicine (Baltimore) 2020;99:e22916.
26. Lin CY, Lee AH, Chiu KK, et al. Saccharomyces cerevisiae Fermentation Product Did Not Attenuate Clinical Signs, but Psyllium Husk Has Protective Effects in a Murine Dextran Sulfate Sodium-Induced Colitis Model. Curr Dev Nutr 2020;4:nzaa159.
27. Rizvi W, Fayazuddin M, Shariq S, et al. Anti-inflammatory activity of roots of Cichorium intybus due to its inhibitory effect on various cytokines and antioxidant activity. Anc Sci Life 2014;34:44-49.
28. So D, Whelan K, Rossi M, et al. Dietary fiber intervention on gut microbiota composition in healthy adults: a systematic review and meta-analysis. Am J Clin Nutr 2018;107:965-983.