Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, doubleblind, placebo controlled, multi-centre, pilot clinical study (original) (raw)

Keywords: probiotic, B. coagulans MTCC 5856, LactoSpore®, major depression, irritable bowel syndrome

Abstract

Background: The modification of microbial ecology in human gut by supplementing probiotics may be an alternative strategy to ameliorate or prevent depression.

Objective: The current study was conducted to assess the safety and efficacy of the probiotic strain Bacillus coagulans MTCC 5856 for major depressive disorder (MDD) in IBS patients.

Method: Patients (n = 40) diagnosed for MDD with IBS were randomized (1:1) to receive placebo or B. coagulans MTCC 5856 at a daily dose of 2 × 109 cfu (2 billion spores) and were maintained to the end of double-blind treatment (90 days). Changes from baseline in clinical symptoms of MDD and IBS were evaluated through questionnaires.

Results: Significant change (p = 0.01) in favour of the B. coagulans MTCC 5856 was observed for the primary efficacy measure Hamilton Rating Scale for Depression (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Center for Epidemiological Studies Depression Scale (CES-D) and Irritable bowel syndrome quality of life questionnaire (IBS-QOL). Secondary efficacy measures i.e. Clinical Global Impression-Improvement rating Scale (CGI-I), Clinical Global Impression Severity rating Scale (CGI-S), Gastrointestinal Discomfort Questionnaire (GI-DQ) and Modified Epworth Sleepiness Scale (mESS) also showed significant results (p = 0.01) in B. coagulans MTCC 5856 group compared to placebo group except dementia total reaction scoring. Serum myeloperoxidase, an inflammatory biomarker was also significantly reduced (p < 0.01) when compared with the baseline and end of the study. All the safety parameters remained well within the normal clinical range and had no clinically significant difference between the screening and at the end of the study.

Conclusion: B. coagulans MTCC 5856 showed robust efficacy for the treatment of patients experiencing IBS symptoms with major depressive disorder. The improvement in depression and IBS symptoms was statistically significant and clinically meaningful. These findings support B. coagulans MTCC 5856 as an important new treatment option for major depressive disorder in IBS patients. Trial Registration: Clinical Trials Registry India Identifier: CTRI/2015/05/005754

Downloads

Download data is not yet available.

References

  1. Uher R, Payne JL, Pavlova B, Perlis RH. Major depressive disorder in DSM-5: implications for clinical practice and research of changes from DSM-IV. Depress Anxiety 2014; 31: 459–71.

  2. World Health Organization (WHO). Depression. Available from: http://www.who.int/mental_health/management/depression/en/. 2009. Retrieved December 30, 2017.

  3. CBHSQ. Center for Behavioral Health Statistics and Quality. Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health (HHS Publication No. SMA 15-4927, NSDUH Series H-50). 2015; Available from http://www.samhsa.gov/data/. Retrieved December 30, 2017.

  4. Shilyansky C, Williams LM, Gyurak A, Harris A, Usherwood T, Etkin A. Effect of antidepressant treatment on cognitive impairments associated with depression: a randomised longitudinal study. Lancet Psychiatry 2016; 3(5): 425–35.

  5. Hoifodt RS, Strom C, Kolstrup N, Eisemann M, Waterloo K. Effectiveness of cognitive behavioural therapy in primary health care: a review. Fam Pract 2011; 28(5): 489–504.

  6. World Gastroenterology Organization (WGO). Irritable bowel syndrome: a global perspective. World Gastroenterology Organisation Global Guideline. Available from: http://www.jupiterpharma.in/journalpdf/IBS WORLD GASTRO.pdf. 2009. Retrieved December 30, 2017.

  7. Ford AC, Quigley EM, Lacy BE, Lembo AJ, Saito YA, Schiller LR, et al. Efficacy of prebiotics, probiotics, and synbiotics in irritable bowel syndrome and chronic idiopathic constipation: systematic review and meta-analysis. Am J Gastroenterol 2014; 109: 1547–61.

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

  9. Canavan C, West J, Card T. The epidemiology of irritable bowel syndrome. Clin Epidemiol 2014; 6: 71–80.

  10. Chen C-H, Lin C-L, Kao C-H. Irritable bowel syndrome is associated with an increased risk of dementia: a nationwide population-based study. PLoS One 2016; 11(1): e0144589.

  11. Sekirov I, Russell SL, Antunes LC. Gut microbiota in health and disease. Physiol Rev 2010; 90: 859–904.

  12. Sender R, Fuchs S, Milo R. Are we really vastly outnumbered? Revisiting the ratio of bacterial to host cells in humans. Cell 2016; 164: 337–40.

  13. Carding S, Verbeke K, Vipond DT, Corfe BM, Owen LJ. Dysbiosis of the gut microbiota in disease. Microb Ecol Health Dis 2015; 26: 26191.

  14. Moschopoulos C, Kratimenos P, Koutroulis I, Shah BV, Mowes A, Bhandari V. The neurodevelopmental perspective of surgical necrotizing enterocolitis: the role of the gut-brain axis. Mediators Inflamm 2018; 7456857: 1–8.

  15. De Palma G, Collins SM, Bercik P, Verdu EF. The microbiota–gut–brain axis in gastrointestinal disorders: stressed bugs, stressed brain or both? J Physiol 2014; 592: 2989–97.

  16. Ledochowski M, Widner B, Sperner-Unterweger B. Carbohydrate malabsorption syndromes and early signs of mental depression in females. Dig Dis Sci 2000; 45: 1255–9.

  17. Berer K, Krishnamoorthy G. Commensal gut flora and brain autoimmunity: a love or hate affair? Acta Neuropathol 2012; 123: 639–51.

  18. FAO/WHO (2002). Report of a joint FAO/WHO expert consultation on guidelines for the evaluation of probiotics in food. London: World Health Organization and Food and Agriculture Organization of the United Nations.

  19. Krabbe KS, Reichenberg A, Yirmiya R. Low-dose endotoxemia and human neuropsychological functions. Brain Behav Immun 2005; 19: 453–60.

  20. Steenbergen L, Sellaro R, van Hemert S, Bosch JA, Colzato LS. A randomized controlled trial to test the effect of multispecies probiotics on cognitive reactivity to sad mood. Brain Behav Immun 2015; 48: 258–64.

  21. Majeed M, Nagabhushanam K, Natarajan S, Sivakumar A, Eshuis-de Ruiter T, Booij-Veurink J, et al. Evaluation of genetic and phenotypic consistency of Bacillus coagulans MTCC 5856: a commercial probiotic strain. World J Microbiol Biotechnol 2016; 32: 60.

  22. 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.

  23. Majeed M, Majeed S, Nagabhushanam K, Natarajan S, Sivakumar A, Ali F, et al. Evaluation of the stability of Bacillus coagulans MTCC 5856 during processing and storage of functional foods. Int J Food Sci Technol 2016; 51(4): 894–901.

  24. Majeed M, Natarajan S, Sivakumar A, Ali F, Pande A, Majeed S, et al. Evaluation of anti-diarrhoeal activity of Bacillus coagulans MTCC 5856 and its effect on gastrointestinal motility in Wistar rats. Int J Pharma Bio Sci 2016; 7: 311–16.

  25. Majeed M, Nagabhushanam K, Natarajan S, Sivakumar A, Pande A, Majeed S, et al. A double-blind, placebo-controlled, parallel study evaluating the safety of Bacillus coagulans MTCC 5856 in healthy individuals. J Clin Toxicol 2016; 6: 283.

  26. Choung RS, Locke GR III, Zinsmeister AR, Schleck CD, Talley NJ. Psychosocial distress and somatic symptoms in community subjects with irritable bowel syndrome: a psychological component is the rule. Am J Gastroenterol 2009; 104: 1772–9.

  27. Lacy BE, Weiser K, Noddin L, Robertson DJ, Crowell MD, Parratt-Engstrom C, et al. Irritable bowel syndrome: patients’ attitudes, concerns and level of knowledge. Aliment Pharmacol Ther 2007; 25: 1329–41.

  28. Sampson TR, Mazmanian SK. Control of brain development, function, and behavior by the microbiome. Cell Host Microbe 2015; 17(5): 565–76.

  29. Anonymous, 52nd WMA General Assembly, Edinburgh, Scotland. 2000. Available from: http://www.wma.net/en/30publications/10policies/b3/. Retrieved December 10, 2017.

  30. Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology 2006; 130: 1377–90.

  31. Friedrich M, Grady SE, Wall GC. Effects of antidepressants in patients with irritable bowel syndrome and comorbid depression. Clin Ther 2010; 32, 1221–33.

  32. Kim HJ, Camilleri M, McKinzie S, Lempke MB, Burton DD, Thomforde GM, et al. A randomized controlled trial of a probiotic, VSL#3 on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther 2003; 17: 895–904.

  33. Bravo JA, Forsythe P, Chew MV, Escaravage E, Savignac HM, Dinan TG, et al. Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. Proc Natl Acad Sci USA 2011; 108: 16050–5.

  34. Kim HJ, Vazquez Roque MI, Camilleri M, Stephens D, Burton DD, Baxter K, et al. A randomized controlled trial of a probiotic combination VSL#3 and placebo in irritable bowel syndrome with bloating. Neurogastroenterol Motil 2005; 17: 687–96.

  35. Tsuchiya J, Barreto R, Okura R, Kawakita S, Fesce E, Marotta F. Single blind follow-up study on the effectiveness of a symbiotic preparation in irritable bowel syndrome. Chin J Dig Dis 2004; 5: 169–74.

  36. Baron M. A patented strain of Bacillus coagulans increased immune response to viral challenge. Postgrad Med 2009; 121: 114–18.

  37. Jensen GS, Benson KF. Carter SG. GanedenBC30 cell wall and metabolites: anti-inflammatory and immune modulating effects in vitro. BMC Immunol 2010; 11: 15.

  38. O'Mahony L, McCarthy J, Kelly P, Hurley G, Luo F, Chen K, et al. Lactobacillus and Bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profile. Gastroenterology 2005; 128: 541–51.

  39. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991; 14: 540–5.

  40. Desbonnet L, Garrett L, Clarke G, Kiely B, Cryan JF, Dinan TG. Effects of the probiotic Bifidobacterium infantis in the maternal separation model of depression. Neuroscience 2010; 170: 1179–88.

  41. Messaoudi M, Violle N, Bisson JF, Desor D, Javelot H, Rougeot C. Beneficial psychological effects of a probiotic formulation (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) in healthy human volunteers. Gut Microbes 2011; 2: 256–61.

  42. Pinto-Sanchez MI, Hall GB, Ghajar K, Nardelli A, Bolino C, Lau JT, et al. Probiotic Bifidobacterium longum NCC3001 reduces depression scores and alters brain activity: a pilot study in patients with irritable bowel syndrome. Gastroenterology 2017; 153(2): 448–59.

  43. Ahmadinejad F, Møller SG, Hashemzadeh-Chaleshtori M, Bidkhori G, Jami MS. Molecular mechanisms behind free radical scavengers function against oxidative stress. Antioxidants 2017; 6: 51.

  44. Talarowska M, Bobin´ska K, Zajączkowska M, Su KP, Maes M, Gałecki P. Impact of oxidative/nitrosative stress and inflammation on cognitive functions in patients with recurrent depressive disorders. Med Sci Monit 2014; 20: 110–15.

  45. Hansberry DR, Shah K, Agarwal P, Agarwal N. Fecal myeloperoxidase as a biomarker for inflammatory bowel disease. Cureus 2017; 9(1):e1004.

  46. Toribio-Mateas M. Harnessing the power of microbiome assessment tools as part of neuroprotective nutrition and lifestyle medicine interventions. Microorganisms 2018; 6(2): 1–32.

  47. Majeed M, Majeed S, Nagabhushanam K, Arumugam S, Natarajan S, Beede K, et al. Galactomannan from Trigonella foenum_−_graecum L. seed: prebiotic application and its fermentation by the probiotic Bacillus coagulans strain MTCC 5856. Food Sci Nutri 2018; 6(3): 666–73.

  48. Majeed M, Nagabhushanam K, Arumugam S, Natarajan S, Majeed S, Beede K, et al. Cranberry seed fiber: a promising prebiotic fiber and its fermentation by the probiotic Bacillus coagulans MTCC 5856. Int J Food Sci Technol 2018. doi: 10.1111/ijfs.13747. Int J Food Sci Technol 2018; 53(7): 1640–1647.

  49. EFSA. BIOHAZ Panel (EFSA Panel on Biological Hazards). Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2013 update). EFSA J 2013; 11(11): 3449, 107 pp.

How to Cite

Majeed M., Nagabhushanam K., Arumugam S., Majeed S., & Ali F. (2018). Bacillus coagulans</em> MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, doubleblind, placebo controlled, multi-centre, pilot clinical study. Food & Nutrition Research, 62. https://doi.org/10.29219/fnr.v62.1218

Section

Original Articles