DOI: https://dx.doi.org/10.18203/2319-2003.ijbcp20222353
Published: 2022-09-14

Evaluation of efficacy and safety of Bacillus coagulans SNZ 1969 supplementation for irritable bowel syndrome: a randomized, double-blind, placebo-controlled study

Raunak J. Soman, Sarath Chandra Gorantla, Malisetty Venkat Swamy

Abstract


Background: Probiotic potential (efficacy and safety) of Bacillus coagulans SNZ 1969 has been studied in patients with constipation-predominant irritable bowel syndrome (IBS-C) and-diarrhea predominant IBS (IBS-D).

Methods: This randomized, double-blind, two-arm, placebo-controlled parallel study randomized 92 patients (1:1) to receive either 500 million CFU of Bacillus coagulans SNZ 1969 (treatment group) or placebo (placebo group) twice daily for 60 days under two subtypes of IBS, IBS-D (n=46) and IBS-C (n=46). Primary outcomes were changes in IBS symptom severity noted using the gastrointestinal symptom rating scale-IBS version (GSRS-IBS) on days 30, 60, and 75, and the number of treatment responders defined by subject’s global assessment (SGA) of relief ≤3 and ≤2 at days 30 and 60, respectively. We also assessed patient’s quality of life.

Results: The GSRS-IBS scores reduced from day 30 through 75 in both IBS groups treated with Bacillus coagulans SNZ1969 compared to placebo (p<0.05). Higher GSRS-IBS score was noted in patients with IBS-C in the treatment group (22.45±2.7) than the placebo group (3.55±3.02; p<0.0001), and this trend was similar in IBS-D patients (p<0.0001). Most patients (90%) with IBS-C and all with IBS-D responded to Bacillus coagulans SNZ 1969 compared to no responders with placebo (p<0.0001). The SF-8 scores significantly reduced in patients receiving Bacillus coagulans SNZ 1969 than placebo for both IBS subtypes. One adverse event unrelated to the study treatments was reported in IBS-D group.

Conclusions: Bacillus coagulans SNZ 1969 is safe, effective in alleviating IBS-associated clinical symptoms, and improves quality of life.


Keywords


Bacillus coagulans, Gastrointestinal symptom rating scale, Functional gastrointestinal disorder, Lactic acid-producing bacteria, Probiotics, SF-8 health survey, IBS-C, IBS-D, SNZ 1969

Full Text:

PDF

References


Simon E, Călinoiu LF, Mitrea L, Vodnar DC. Probiotics, prebiotics, and synbiotics: Implications and beneficial effects against irritable bowel syndrome. Nutrients. 2021;13(6):2112.

Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012;10(7):712-21.

Chatila R, Merhi M, Hariri E, Sabbah N, Deeb ME. Irritable bowel syndrome: prevalence, risk factors in an adult Lebanese population. BMC Gastroenterol. 2017;17(1):1-6.

Fadgyas-Stanculete M, Buga A-M, Popa-Wagner A, Dumitrascu DL. The relationship between irritable bowel syndrome and psychiatric disorders: from molecular changes to clinical manifestations. J Molecular Psychiatry. 2014;2(1):1-7.

Gralnek IM, Hays RD, Kilbourne A, Naliboff B, Mayer EA. The impact of irritable bowel syndrome on health-related quality of life. Gastroenterol. 2000;119(3):654-60.

Ballou S, Keefer L. The impact of irritable bowel syndrome on daily functioning: Characterizing and understanding daily consequences of IBS. Neurogastroenterol Motil. 2017;29(4):10.1111/nmo.12982.

Galica AN, Galica R, Dumitrașcu DL. Diet, fibers, and probiotics for irritable bowel syndrome. J Med Life. 2022;15(2):174-9.

Masuy I, Pannemans J, Tack J. Irritable bowel syndrome: diagnosis and management. Minerva gastroenterologica e dietologica. 2019;66(2):136-50.

Van Zyl WF, Deane SM, Dicks LMT. Molecular insights into probiotic mechanisms of action employed against intestinal pathogenic bacteria. Gut Microbes. 2020;12(1):1831339.

Gupta AK, Maity C. Efficacy and safety of Bacillus coagulans LBSC in irritable bowel syndrome: A prospective, interventional, randomized, double-blind, placebo-controlled clinical study [CONSORT Compliant]. Medicine. 2021;100(3):e23641.

Abhari K, Saadati S Hosseini-Oskouiee F, Yari Z, Hosseini H, Sohrab G et al. Is Bacillus coagulans supplementation plus low FODMAP diet superior to low FODMAP diet in irritable bowel syndrome management?. Eur J Nutr. 2020;59(5):2111-7.

Rogha M, Esfahani MZ, Zargarzadeh AH. The efficacy of a synbiotic containing Bacillus Coagulans in treatment of irritable bowel syndrome: a randomized placebo-controlled trial. Gastroenterol Hepatol Bed Bench. 2014;7(3):156.

Hun L. Bacillus coagulans significantly improved abdominal pain and bloating in patients with IBS. Postgraduate Med. 2009;121(2):119-24.

Madempudi RS, Ahire JJ, Neelamraju J, Tripathi A, Nanal S. Randomized clinical trial: the effect of probiotic Bacillus coagulans Unique IS2 vs. placebo on the symptoms management of irritable bowel syndrome in adults. Scientific Rep. 2019;9(1):1-9.

Maity C, Gupta PhD AK, Saroj DB, Biyani A, Bagkar P, Kulkarni J et al. Impact of a gastrointestinal stable probiotic supplement Bacillus coagulans LBSC on human gut microbiome modulation. J Dietary Suppl. 2021;18(6):577-96.

Majeed M, Nagabhushanam K, Natarajan S, Sivakumar A, Ali F, Pande A et al. Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study. Nutrition J. 2015;15(1):1-10.

Soman RJ, Singh K, Swamy MV. Efficacy and Safety of Probiotic Bacillus coagulans-SNZ 1969 in Gastrointestinal Discomfort: A Randomized, Placebo-Controlled Study. Int J Health Sci Res. 2022;12(3):253-64.

Soman RJ, Swamy MV. A prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of SNZ TriBac, a three-strain Bacillus probiotic blend for undiagnosed gastrointestinal discomfort. Int J Colorectal Dis. 2019;34(11):1971-8.

Majeed M, Nagabhushanam K, Natarajan S, Sivakumar A, Ali F, Pande A et al. Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study. Nutr J. 2016;15:21.

Wiklund IK, Fullerton S, Hawkey CJ, Jones RH, Longstreth GF, Mayer EA et al. An irritable bowel syndrome-specific symptom questionnaire: development and validation. Scand J Gastroenterol. 2003;38(9):947-54.

Ljótsson B, Jones M, Talley NJ, Kjellström L, Agréus L, Andreasson A. Discriminant and convergent validity of the GSRS-IBS symptom severity measure for irritable bowel syndrome: a population study. United European Gastroenterol J. 2020;8(3):284-92.

Müller-Lissner S, Koch G, Talley NJ, Drossman D, Rueegg P, Dunger-Baldauf C, Lefkowitz M (2003) Subject's Global Assessment of Relief: an appropriate method to assess the impact of treatment on irritable bowel syndrome-related symptoms in clinical trials. J Clin Epidemiol 56(4):310-6.

Yiengprugsawan V, Kelly M, Tawatsupa B. SF-8TM Health Survey. In: Michalos AC, ed. Encyclopedia of Quality of Life and Well-Being Research. Springer Netherlands. 2014;5940-2.

Black CJ, Ford AC. Global burden of irritable bowel syndrome: trends, predictions and risk factors. Nature Rev Gastroenterol Hepatol. 2020;17(8):473-86.

Buono JL, Carson RT, Flores NM. Health-related quality of life, work productivity, and indirect costs among patients with irritable bowel syndrome with diarrhea. Health Quality Life Outcomes. 2017;15(1):1-8.

Liang D, Longgui N, Guoqiang X. Efficacy of different probiotic protocols in irritable bowel syndrome: A network meta-analysis. Medicine. 2019;98(27):e16068.

McFarland LV, Karakan T, Karatas A. Strain-specific and outcome-specific efficacy of probiotics for the treatment of irritable bowel syndrome: A systematic review and meta-analysis. E-Clin-Medic. 2021;41:101154.

Xu HL, Zou LL, Chen MB, Wang H, Shen WM, Zheng QH et al. Efficacy of probiotic adjuvant therapy for irritable bowel syndrome in children: A systematic review and meta-analysis. Plos one. 2021;16(8):e0255160.

Zhang T, Zhang C, Zhang J, Sun F, Duan L. Efficacy of Probiotics for Irritable Bowel Syndrome: A Systematic Review and Network Meta-Analysis. Front Cellular Infect Microbiol. 2022;12:859967.

Le Morvan de Sequeira C, Kaeber M, Cekin SE, Enck P, Mack I. The effect of probiotics on quality of life, depression and anxiety in patients with irritable bowel syndrome: a systematic review and meta-analysis. J Clin Med. 2021;10(16):3497.

Li B, Liang L, Deng H, Guo J, Shu H, Zhang L. Efficacy and safety of probiotics in irritable bowel syndrome: A systematic review and meta-analysis. Front Pharmacol. 2020;11:332.

Zhang Y, Li L, Guo C, Mu D, Feng B, Zuo X et al. Effects of probiotic type, dose and treatment duration on irritable bowel syndrome diagnosed by Rome III criteria: a meta-analysis. BMC Gastroenterol. 2016;16(1):1-11.