Efficacy of UB0316, a multi-strain probiotic formulation in patients with type 2 diabetes mellitus: A double blind, randomized, placebo controlled study
Autoři:
Ratna Sudha Madempudi aff001; Jayesh J. Ahire aff001; Jayanthi Neelamraju aff001; Anirudh Tripathi aff002; Satyavrat Nanal aff003
Působiště autorů:
Centre for Research & Development, Unique Biotech Ltd., Alexandria Knowledge Park, Hyderabad, Telangana, India
aff001; Life Veda Treatment and Research Centre, Worli, Mumbai, India
aff002; Nanal Clinic, Anand Bhuvan, Gore wadi, Mahim (W), Mumbai, India
aff003
Vyšlo v časopise:
PLoS ONE 14(11)
Kategorie:
Research Article
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pone.0225168
Souhrn
Background
Role of multi-strain probiotic formulations in the management of type 2 diabetes mellitus (T2DM) has rarely been reported. In the present study, the effects of the probiotic formulation, UB0316 (L. salivarius UBLS22, L. casei UBLC42, L. plantarum UBLP40, L. acidophilus UBLA34, B. breve UBBr01, B. coagulans Unique IS2, 5 billion CFU each and fructo-oligosaccharides, 100 mg) in patients with T2DM were assessed.
Methods
A total of 79 eligible subjects (18–65 years, on stable metformin therapy) were randomly assigned to receive UB0316 or placebo, twice-a-day for 12 weeks. The primary endpoint was change in glycated hemoglobin (HbA1c), secondary were assessment of blood glucose levels, HOMA-IR (homeostatic model assessment of insulin resistance), insulin, body weight, and blood lipids. Quality of life, vital signs, physical investigations, safety and Physician/Subject’s Global assessment were also evaluated.
Results
Twelve week multi-strain probiotic (UB0316) supplementation significantly reduced HbA1c (7.70 ± 0.79%; p = 0.0023) and weight (67.00 ± 8.82 kg; p < 0.001) as compared to placebo (HbA1c: 8.30 ± 1.35%; weight: 67.60 ± 9.46 kg). The changes recorded in fasting blood glucose (FBG), HOMA-IR, insulin, TC, TG, HDL, and LDL levels were however not significantly altered as compared to placebo. No severe adverse events, abnormal vital and physical signs were reported. The quality of life of T2DM was significantly improved.
Conclusions
UB0316 significantly improved glycemic control as indicated by the decrease in HbA1c levels. There was also a significant decrease in weight in the probiotic treated subjects as compared to placebo.
Klíčová slova:
Insulin – Quality of life – Mental health and psychiatry – Blood sugar – Lipoproteins – Probiotics
Zdroje
1. DeFronzo RA, Ferrannini E, Groop L, Henry RR, Herman WH, Holst JJ, et al. Type 2 diabetes mellitus. Nat Rev Dis Primers. 2015;1:15019. doi: 10.1038/nrdp.2015.19 27189025
2. International Diabetes Federation (IDF). IDF Diabetes Atlas, 8th Edition, http://www.diabetesatlas.org (2017).
3. World Health Organization (WHO). Diabetes. http://www.who.int/news-room/fact-sheets/detail/diabetes Accessed October 03, 2018.
4. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2012;55:1577–1596. doi: 10.1007/s00125-012-2534-0 22526604
5. Han JL, Lin HL. Intestinal microbiota and type 2 diabetes: from mechanism insights to therapeutic perspective. World J Gastroenterol. 2014;20:17737–17745. doi: 10.3748/wjg.v20.i47.17737 25548472
6. Larsen N, Vogensen FK, van den Berg FW, Nielsen DS, Andreasen AS, Pedersen BK, et al. Gut microbiota in human adults with type 2 diabetes differs from non-diabetic adults. PloS One. 2010;5:e9085. doi: 10.1371/journal.pone.0009085 20140211
7. Allcock GH, Allegra M, Flower RJ, Perretti M. Neutrophil accumulation induced by bacterial lipopolysaccharide: effects of dexamethasone and annexin 1. Clin Exp Immunol. 2001;123:62–67. doi: 10.1046/j.1365-2249.2001.01370.x 11167999
8. Sato J, Kanazawa A, Azuma K, Ikeda F, Goto H, Komiya K, et al. Probiotic reduces bacterial translocation in type 2 diabetes mellitus: A randomised controlled study. Sci Rep. 2017;7:12115. doi: 10.1038/s41598-017-12535-9 28935921
9. Aw W, Fukuda S. Understanding the role of the gut ecosystem in diabetes mellitus. J Diabetes Investig. 2018;9:5–12. doi: 10.1111/jdi.12673 28390093
10. Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, et al. The international scientific association for probiotics and prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014;11:506–514. doi: 10.1038/nrgastro.2014.66 24912386
11. Yao K, Zeng L, He Q, Wang W, Lei J, Zou X. Effect of probiotics on glucose and lipid metabolism in type 2 diabetes mellitus: a meta-analysis of 12 randomized controlled trials. Med Sci Monit. 2017;23:3044. doi: 10.12659/MSM.902600 28638006
12. Lv Y, Zhao X, Guo W, Gao Y, Yang S, Li Z, et al. The relationship between frequently used glucose-lowering agents and gut microbiota in type 2 diabetes mellitus. J Diabetes Res. 2018; 1890978. doi: 10.1155/2018/1890978 29854817
13. Brunkwall L, Orho-Melander M. The gut microbiome as a target for prevention and treatment of hyperglycaemia in type 2 diabetes: from current human evidence to future possibilities. Diabetologia. 2017;60:943–951. doi: 10.1007/s00125-017-4278-3 28434033
14. Forslund K, Hildebrand F, Nielsen T, Falony G, Le Chatelier E, Sunagawa S, et al. Disentangling type 2 diabetes and metformin treatment signatures in the human gut microbiota. Nature. 2015;528:262–266. doi: 10.1038/nature15766 26633628
15. Sudha MR, Radkar N, Maurya A. Effect of supplementation of probiotic Bacillus coagulans Unique IS-2 (ATCC PAT-11748) on hypercholesterolemic subjects: a clinical study. Int J Probiotics and Prebiotics. 2011;6:89–93.
16. Rajkumar H, Kumar M, Das N, Kumar SN, Challa HR, Nagpal R. Effect of probiotic Lactobacillus salivarius UBL S22 and prebiotic fructo-oligosaccharide on serum lipids, inflammatory markers, insulin sensitivity, and gut bacteria in healthy young volunteers: a randomized controlled single-blind pilot study. J Cardiovasc Pharmacol Ther. 2015; 20:289–298. doi: 10.1177/1074248414555004 25331262
17. Pawar RR, Pardeshi ML, Ghongane BB. Study of effects of probiotic lactobacilli in preventing major complications in patients of liver cirrhosis. Int J Res Pharm Biomed Sci. 2012;3:206–211.
18. Sudha MR, Jayanthi N, Aasin M, Dhanashri RD, Anirudh T. Efficacy of Bacillus coagulans Unique IS2 in treatment of irritable bowel syndrome in children: a double blind, randomised placebo controlled study. Benef Microbes. 2018;9:563–572. doi: 10.3920/BM2017.0129 29695183
19. 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. Sci Rep. 2019;9:12210 doi: 10.1038/s41598-019-48554-x 31434935
20. Saneian H, Pourmoghaddas Z, Roohafza H, Gholamrezaei A. Synbiotic containing Bacillus coagulans and fructo-oligosaccharides for functional abdominal pain in children. Gastroenterol Hepatol Bed Bench. 2015;8:56. 25584177
21. Sudha RM, Bhonagiri S. Efficacy of Bacillus coagulans strain Unique IS-2 in the treatment of patients with acute diarrhea. Int J Probiotics and Prebiotics. 2012;7:33–37.
22. Madempudi RS, Neelamraju J, Ahire JJ, Gupta SK, Shukla VK. Bacillus coagulans Unique IS2 in constipation: a double-blind, placebo-controlled study. Probiotics & Antimicro Prot. 2019;1–8. https://doi.org/10.1007/s12602-019-09542-9.
23. Venkataraman R, Jose P, Jose J. Impact of probiotics on health-related quality of life in Type II diabetes mellitus: a randomized single-blind, placebo-controlled study. J Nat Sci Biol Med. 2019;10: 2. https://doi.org/10.4103/jnsbm.JNSBM_31_18.
24. Nagpal J, Kumar A, Kakar S, Bhartia A. The development of quality of life instrument for Indian diabetes patients (QOLID): a validation and reliability study in middle and higher income groups. J Assoc Physicians India. 2010;58:295–304. 21117348
25. Clark GT, Mulligan R. Fifteen common mistakes encountered in clinical research. J Prosthodont Res. 2011;55:1–6. doi: 10.1016/j.jpor.2010.09.002 21095178
26. Florkowski C. HbA1c as a diagnostic test for diabetes mellitus–reviewing the evidence. Clin Biochem Rev. 2013;34:75–83. 24151343
27. Kobyliak N, Falalyeyeva T, Mykhalchyshyn G, Kyriienko D, Komissarenko I. Effect of alive probiotic on insulin resistance in type 2 diabetes patients: randomized clinical trial. Diabetes Metab Syndr: Clin Res Rev. 2018;12:617–624.
28. Mobini R, Tremaroli V, Ståhlman M, Karlsson F, Levin M, Ljungberg M, et al. Metabolic effects of Lactobacillus reuteri DSM 17938 in people with type 2 diabetes: a randomized controlled trial. Diabetes Obes Metab. 2017;19:579–589. doi: 10.1111/dom.12861 28009106
29. Mohamadshahi M, Veissi M, Haidari F, Javid AZ, Mohammadi F, Shirbeigi E. Effects of probiotic yogurt consumption on lipid profile in type 2 diabetic patients: a randomized controlled clinical trial. J Res Med Sci. 2014;19:531–536. 25197295
30. Ostadrahimi A, Taghizadeh A, Mobasseri M, Farrin N, Payahoo L, Gheshlaghi ZB, et al. Effect of probiotic fermented milk (kefir) on glycemic control and lipid profile in type 2 diabetic patients: a randomized double-blind placebo-controlled clinical trial. Iran J Public Health. 2015;44:228–237. 25905057
31. Tonucci LB, dos Santos KM, de Oliveira LL, Ribeiro SM, Martino HS. Clinical application of probiotics in type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study. Clin Nutr. 2017;36:85–92. doi: 10.1016/j.clnu.2015.11.011 26732026
32. Ruan Y, Sun J, He J, Chen F, Chen R, Chen H. Effect of probiotics on glycemic control: a systematic review and meta-analysis of randomized, controlled trials. PloS One 2015;10:e0132121. doi: 10.1371/journal.pone.0132121 26161741
33. Ozder A. Lipid profile abnormalities seen in T2DM patients in primary healthcare in Turkey: a cross-sectional study. Lipids Health Dis. 2014;13:183. doi: 10.1186/1476-511X-13-183 25481115
34. Lin SH, Cheng PC, Te Tu S, Hsu SR, Cheng YC, Liu YH. Effect of metformin monotherapy on serum lipid profile in statin-naïve individuals with newly diagnosed type 2 diabetes mellitus: a cohort study. PeerJ. 2018;6:e4578. doi: 10.7717/peerj.4578 29666753
35. Sabico S, Al-Mashharawi A, Al-Daghri NM, Yakout S, Alnaami AM, Alokail MS, et al. Effects of a multi-strain probiotic supplement for 12 weeks in circulating endotoxin levels and cardiometabolic profiles of medication naïve T2DM patients: a randomized clinical trial. J Transl Med. 2017;15:249. doi: 10.1186/s12967-017-1354-x 29228964
36. Chobot A, Górowska‐Kowolik K, Sokołowska M, Jarosz‐Chobot P. Obesity and diabetes–not only a simple link between two epidemics. Diabetes Metab Res Rev. 2018;34:e3042. doi: 10.1002/dmrr.3042 29931823
37. Wilding JPH. The importance of weight management in type 2 diabetes mellitus. Int J Clin Pract. 2014;68:682–691. doi: 10.1111/ijcp.12384 24548654
38. John G, Wang L, Nanavati J, Twose C, Singh R, Mullin G. Dietary alteration of the gut microbiome and its impact on weight and fat mass: a systematic review and meta-analysis. Genes. 2018;9:167.
39. Feng X, Astell-Burt T. Impact of a type 2 diabetes diagnosis on mental health, quality of life, and social contacts: a longitudinal study. BMJ Open Diabetes Res Care. 2017;5:e000198. doi: 10.1136/bmjdrc-2016-000198 28243446
Článok vyšiel v časopise
PLOS One
2019 Číslo 11
- Metamizol jako analgetikum první volby: kdy, pro koho, jak a proč?
- Nejasný stín na plicích – kazuistika
- Masturbační chování žen v ČR − dotazníková studie
- Úspěšná resuscitativní thorakotomie v přednemocniční neodkladné péči
- Dlouhodobá recidiva a komplikace spojené s elektivní operací břišní kýly
Najčítanejšie v tomto čísle
- A daily diary study on maladaptive daydreaming, mind wandering, and sleep disturbances: Examining within-person and between-persons relations
- A 3’ UTR SNP rs885863, a cis-eQTL for the circadian gene VIPR2 and lincRNA 689, is associated with opioid addiction
- A substitution mutation in a conserved domain of mammalian acetate-dependent acetyl CoA synthetase 2 results in destabilized protein and impaired HIF-2 signaling
- Molecular validation of clinical Pantoea isolates identified by MALDI-TOF