Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study
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 d...
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| Format: | Article |
| Language: | English |
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Swedish Nutrition Foundation
2018-07-01
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| Series: | Food & Nutrition Research |
| Subjects: | |
| Online Access: | https://foodandnutritionresearch.net/index.php/fnr/article/view/1218/4800 |
| _version_ | 1818138304699170816 |
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| author | Muhammed Majeed Kalyanam Nagabhushanam Sivakumar Arumugam Shaheen Majeed Furqan Ali |
| author_facet | Muhammed Majeed Kalyanam Nagabhushanam Sivakumar Arumugam Shaheen Majeed Furqan Ali |
| author_sort | Muhammed Majeed |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-11T10:10:04Z |
| format | Article |
| id | doaj.art-54702f9acee744419b71031865464788 |
| institution | Directory Open Access Journal |
| issn | 1654-661X |
| language | English |
| last_indexed | 2024-12-11T10:10:04Z |
| publishDate | 2018-07-01 |
| publisher | Swedish Nutrition Foundation |
| record_format | Article |
| series | Food & Nutrition Research |
| spelling | doaj.art-54702f9acee744419b710318654647882022-12-22T01:11:46ZengSwedish Nutrition FoundationFood & Nutrition Research1654-661X2018-07-0162011510.29219/fnr.v62.12181218Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical studyMuhammed Majeed0Kalyanam Nagabhushanam1Sivakumar Arumugam2Shaheen Majeed3Furqan Ali41Sami Labs Limited, Bangalore, Karnataka, India2Sabinsa Corporation, East Windsor, NJ, USA1Sami Labs Limited, Bangalore, Karnataka, India2Sabinsa Corporation, East Windsor, NJ, USA1Sami Labs Limited, Bangalore, Karnataka, IndiaBackground: 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.https://foodandnutritionresearch.net/index.php/fnr/article/view/1218/4800probioticB. coagulans MTCC 5856LactoSpore®major depressionirritable bowel syndrome |
| spellingShingle | Muhammed Majeed Kalyanam Nagabhushanam Sivakumar Arumugam Shaheen Majeed Furqan Ali Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study Food & Nutrition Research probiotic B. coagulans MTCC 5856 LactoSpore® major depression irritable bowel syndrome |
| title | Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study |
| title_full | Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study |
| title_fullStr | Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study |
| title_full_unstemmed | Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study |
| title_short | Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study |
| title_sort | bacillus coagulans mtcc 5856 for the management of major depression with irritable bowel syndrome a randomised double blind placebo controlled multi centre pilot clinical study |
| topic | probiotic B. coagulans MTCC 5856 LactoSpore® major depression irritable bowel syndrome |
| url | https://foodandnutritionresearch.net/index.php/fnr/article/view/1218/4800 |
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