Effects of probiotics in patients with diabetes mellitus type 2: Study protocol for a randomized, double-blind, placebo-controlled trial

Trials

Volumn 14, Issue 1, 2013, Pages

  Alokail, Majed S ^a,e   Sabico, Shaun ^a,d   Al Saleh, Yousef ^a   Al Daghri, Nasser M ^a   Alkharfy, Khalid M ^a,b   Vanhoutte, Paul M ^a,c   McTernan, Philip G ^d  

^a KING SAUD UNIVERSITY   (Saudi Arabia)

^b KING SAUD UNIVERSITY   (Saudi Arabia)

^c UNIVERSITY OF HONG KONG   (Hong Kong)

^d UNIVERSITY HOSPITALS COVENTRY AND WARWICKSHIRE NHS TRUST   (United Kingdom)

^e KING SAUD UNIVERSITY   (Saudi Arabia)

Author keywords

Endotoxin; Microbiota; Probiotics; Type 2 diabetes mellitus

Indexed keywords

BIOLOGICAL MARKER; ECOLOGIC; ENDOTOXIN; PLACEBO; PROBIOTIC AGENT; UNCLASSIFIED DRUG;

ARTICLE; COMORBIDITY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; HUMAN; INFLAMMATION; INTESTINE FLORA; MAJOR CLINICAL STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; RANDOMIZED CONTROLLED TRIAL; UNSPECIFIED SIDE EFFECT;

BACTERIA; BIOLOGICAL MARKERS; CLINICAL PROTOCOLS; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; ENDOTOXINS; FECES; HUMANS; INFLAMMATION MEDIATORS; INTESTINES; PROBIOTICS; RESEARCH DESIGN; SAUDI ARABIA; TIME FACTORS; TREATMENT OUTCOME;

EID: 84879816433     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-195     Document Type: Article

References (50)

1. Backhed F, Ley RE, Sonnenburg JL, Peterson DA, Gordon JI. Host-bacterial mutualism in the human intestine. Science 2005, 307:1915-1920. 10.1126/science.1104816, 15790844.
2. Husebye E, Hellstrom PM, Sundler F, Chen J, Midtvedt T. Influence of microbial species on small intestinal myoelectric activity and transit in germ-free rats. Am J Physiol Gastrointest Liver Physiol 2001, 280:G368-G380.
3. O'Hara AM, Shanahan F. The gut flora as a forgotten organ. EMBO Rep 2006, 7:688-693. 10.1038/sj.embor.7400731, 1500832, 16819463.
4. Al-Attas OS, Al-Daghri NM, Al-Rubeaan K, da Silva NF, Sabico SL, Kumar S, McTernan PG, Harte AL. Changes in endotoxin levels in T2DM subjects on anti-diabetic therapies. Cardiovasc Diabetol 2009, 8:20. 10.1186/1475-2840-8-20, 2674418, 19368716.
5. Baker AR, Harte AL, Howell N, Pritlove DC, Ranasinghe AM, da Silva NF, Youssef EM, Khunti K, Davies MJ, Bonser RS, Kumar S, Pagano D, McTernan PG. Epicardial adipose tissue as a source of nuclear factor-kappaB and c-Jun N-terminal kinase mediated inflammation in patients with coronary artery disease. J Clin Endocrinol Metab 2009, 94:261-267.
6. Brun P, Castagliuolo I, Di Leo V, Buda A, Pinzani M, Palù G, Martines D. Increased intestinal permeability in obese mice: new evidence in the pathogenesis of nonalcoholic steatohepatitis. Am J Physiol Gastrointest Liver Physiol 2007, 292:G518-G525.
7. Creely SJ, McTernan PG, Kusminski CM, Fisher M, Da Silva NF, Khanolkar M, Evans M, Harte AL, Kumar S. Lipopolysaccharide activates an innate immune system response in human adipose tissue in obesity and type 2 diabetes. Am J Physiol Endocrinol Metab 2007, 292:E740-E747.
8. Miller M, McTernan P, Harte A, Silva N, Strazzullo P, Alberti K, Kumar S, Cappuccio F. Ethnic and sex differences in circulating endotoxin levels: a novel marker of atherosclerotic and cardiovascular risk in a British multi-ethnic population. Atherosclerosis 2009, 203:494-502. 10.1016/j.atherosclerosis.2008.06.018, 18672240.
9. Harte AL, da Silva NF, Creely SJ, McGee KC, Billyard T, Youssef-Elabd EM, Tripathi G, Ashour E, Abdalla MS, Sharada HM, Amin AI, Burt AD, Kumar S, Day CP, McTernan PG. Elevated endotoxin levels in non-alcoholic fatty liver disease. J Inflamm (Lond) 2010, 30:7-15.
10. Soares JB, Pimentel-Nunes P, Roncon-Albuquerque R, Leite-Moreira A. The role of lipopolysaccharide/toll-like receptor 4 signaling in chronic liver diseases. Hepatol Int 2010, 4:659-672. 10.1007/s12072-010-9219-x, 2994611, 21286336.
11. Szabo G, Mandrekar P, Petrasek J, Catalano D. The unfolding web of innate immune dysregulation in alcoholic liver injury. Alcohol Clin Exp Res 2011, 35:782-786. 10.1111/j.1530-0277.2010.01398.x, 21284666.
12. Al-Attas OS, Al-Daghri NM, Alokail MS, Al-Fadda A, Bamakhramah A, Sabico S, Pritlove D, Harte A, Tripathi G, McTernan PG, Kumar S, Chrousos G. Adiposity and insulin resistance correlate with telomere length in middle-aged Arabs: the influence of circulating adiponectin. Eur J Endocrinol 2010, 163:601-607. 10.1530/EJE-10-0241, 2938925, 20679357.
13. Al-Attas O, Al-Daghri N, Bamakhramah A, Sabico S, Huang T, McTernan P. Telomere length in relation to insulin resistance, inflammation and obesity among Arab youth. Acta Paediatr 2010, 99:896-899. 10.1111/j.1651-2227.2010.01720.x, 20178511.
14. Dixon AN, Valsamakis G, Hanif MW, Aldaghri N, Field A, Boutsiadis A, Harte AL, McTernan PG, Barnett AH, Kumar S. Effect of the Orlistat on serum endotoxin lipopolysaccharide and adipocytokines in South Asian individuals with impaired glucose tolerance. Int J Clin Pract 2008, 62:1124-1129. 10.1111/j.1742-1241.2008.01800.x, 18564278.
15. Cani PD, Neyrinck AM, Fava F, Knauf C, Burcelin RG, Tuohy KM, Gibson GR, Delzenne NM. Selective increases of bifidobacteria in gut microflora improve high-fat-diet-induced diabetes in mice through a mechanism associated with endotoxaemia. Diabetologia 2007, 50:2374-2383. 10.1007/s00125-007-0791-0, 17823788.
16. Harte AL, Varma MC, Tripathi G, McGee KC, Al-Daghri NM, Al-Attas OS, Sabico S, O'Hare JP, Ceriello A, Saravanan P, Kumar S, McTernan PG. High fat intake leads to acute postprandial exposure to circulating endotoxin in type 2 diabetic subjects. Diabetes Care 2012, 35:375-382. 10.2337/dc11-1593, 3263907, 22210577.
17. Lindstrom J, Neumann A, Sheppard KE, Gilis-Januszewska A, Greaves CJ, Handke U, Pajunen P, Puhl S, Polonen A, Rissanen A, Roden M, Stemper T, Telle-Hjellset V, Tuomilehto J, Velickiene D, Schwarz PE, Acosta T, Adler M, Alkerwi A, Barengo N, Barengo R, Boavida JM, Charlesworth K, Christov V, Claussen B, Cos X, Cosson E, Deceukelier S, Dimitrijevic-Sreckovic V, Djordjevic P, et al. Take action to prevent diabetes-the IMAGE toolkit for the prevention of type 2 diabetes in Europe. Horm Metab Res 2010, 42:S37-S55. 10.1055/s-0029-1240975, 20391307.
18. Schwarz PE, Greaves CJ, Lindstrom J, Yates T, Davies MJ. Nonpharmacological interventions for the prevention of type 2 diabetes mellitus. Nat Rev Endocrinol 2012, 8:363-373.
19. Gorbach SL. Probiotics and gastrointestinal health. Am J Gastroenterol 2000, 95:S2-S4. 10.1016/S0002-9270(99)00806-0, 10634218.
20. Liu Q, Duan ZP, Ha DK, Bengmark S, Kurtovic J, Riordan SM. Synbiotic modulation of gut flora: effect on minimal hepatic encephalopathy in patients with cirrhosis. Hepatology 2004, 39:1441-1449. 10.1002/hep.20194, 15122774.
21. Chiva M, Soriano G. Effect of Lactobacillus jhonsonii La1 and antioxidants on intestinal flora and bacterial translocation in a rat model of experimental cirrhosis. J Hepatol 2000, 36:501-506.
22. Allen SJ, Martinez EG, Gregorio GV, Dans LF. Probiotics for treating acute infectious diarrhoea [review]. Cochrane Database Syst Rev 2010, 10(11):CD003048.
23. Allen SJ, Okoko B, Martinez EG, Gregorio GV, Dans LF. Probiotics for treating infectious diarrhoea. Cochrane Database Syst Rev 2004, 2:CD003048.
24. Checkley W, Buckley G, Gilman RH, Assis AM, Guerrant RL, Morris SS, Mølbak K, Valentiner-Branth P, Lanata CF, Black RE. Childhood malnutrition and infection network. Multi-country analysis of the effects of diarrhoea on childhood stunting. Int J Epidemiol 2008, 37:816-830. 2734063, 18567626.
25. Johnston BC, Supina AL, Ospina M, Vohra S. Probiotics for the prevention of pediatric antibiotic-associated diarrhoea. Cochrane Database Syst Rev 2007, 2:CD004827.
26. Szajewska H, Mrukowicz JZ. Probiotics in the treatment and prevention of acute infectious diarrhoea in infants and children: a systematic review of published randomized, double-blind, placebo-controlled trials. J Pediatr Gastroenterol Nutr 2001, 33:S17-S25.
27. Cremonini F, Di Caro S, Nista EC, Bartolozzi F, Capelli G, Gasbarrini G, Gasbarrini A. Meta-analysis: the effect of probiotic administration on antibiotic-associated diarrhoea. Aliment Pharmacol Ther 2002, 16:1461-1467. 10.1046/j.1365-2036.2002.01318.x, 12182746.
28. Huang JS, Bousvaros A, Lee JW, Diaz A, Davidson EJ. Efficacy of probiotic use in acute diarrhoea in children: a meta-analysis. Dig Dis Sci 2002, 47:2625-2634. 10.1023/A:1020501202369, 12452406.
29. Sazawal S, Hiremath G, Dhingra U, Malik P, Deb S, Black RE. Efficacy of probiotics in prevention of acute diarrhoea: a meta-analysis of masked, randomised, placebo-controlled trials. Lancet Infect Dis 2006, 6:374-382. 10.1016/S1473-3099(06)70495-9, 16728323.
30. Van Niel CW, Feudtner C, Garrison MM, Christakis DA. Lactobacillus therapy for acute infectious diarrhoea in children: a meta-analysis. Pediatrics 2002, 109:678-684. 10.1542/peds.109.4.678, 11927715.
31. Fang SB, Lee HC, Hu JJ, Hou SY, Liu HL, Fang HW. Dose-dependent effect of Lactobacillus rhamnosus on quantitative reduction of faecal rotavirus shedding in children. J Trop Pediatr 2009, 55:297-301. 10.1093/tropej/fmp001, 19203988.
32. Guandalini S, Pensabene L, Zikri MA, Dias JA, Casali LG, Hoekstra H, Kolacek S, Massar K, Micetic-Turk D, Papadopoulou A, de Sousa JS, Sandhu B, Szajewska H, Weizman Z. Lactobacillus GG administered in oral rehydration solution to children with acute diarrhea: a multicenter European trial. J Pediatr Gastroenterol Nutr 2000, 30:54-60. 10.1097/00005176-200001000-00018, 10630440.
33. Henker J, Laass M, Blokhin BM, Bolbot YK, Maydannik VG, Elze M, Wolff C, Schulze J. The probiotic Escherichia coli strain Nissle 1917 (EcN) stops acute diarrhoea in infants and toddlers. Eur J Pediatr 2007, 166:311-318. 10.1007/s00431-007-0419-x, 1802727, 17287932.
34. Moayyedi P, Ford AC, Brandt LJ, Foxx-Orenstein AE, Cremonini F, Talley NJ, Cremonini F, Foxx-Orenstein AE, Brandt LJ, Quigley EM. The efficacy of probiotics in the treatment of irritable bowel syndrome: a systematic review. Gut 2010, 59:325-332. 10.1136/gut.2008.167270, 19091823.
35. Whorwell PJ, Altringer L, Morel J, Bond Y, Charbonneau D, O'Mahony L, Kiely B, Shanahan F, Quigley EM. Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 2006, 101:1581-1590. 10.1111/j.1572-0241.2006.00734.x, 16863564.
36. Turnbaugh PJ, Hamady M, Yatsunenko T, Cantarel BL, Duncan A, Ley RE, Sogin ML, Jones WJ, Roe BA, Affourtit JP, Egholm M, Henrissat B, Heath AC, Knight R, Gordon JI. A core gut microbiome in obese and lean twins. Nature 2009, 457:480-484. 10.1038/nature07540, 2677729, 19043404.
37. Ley RE, Backhed F, Turnbaugh P, Lozupone CA, Knight RD, Gordon JI. Obesity alters gut microbial ecology. Proc Natl Acad Sci U S A 2005, 102:11070-11075. 10.1073/pnas.0504978102, 1176910, 16033867.
38. Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature 2006, 444:1022-1023. 10.1038/4441022a, 17183309.
39. Musso G, Gambino R, Cassader M. Interactions between gut microbiota and host metabolism predisposing to obesity and diabetes. Annu Rev Med 2011, 62:361-380. 10.1146/annurev-med-012510-175505, 21226616.
40. Kootte RS, Vrieze A, Holleman F, Dallinga-Thie GM, Zoetendal EG, de Vos WM, Groen AK, Hoekstra JB, Stroes ES, Nieudrop M. The therapeutic potential of manipulating gut microbiota in obesity and type 2 diabetes mellitus. Diabetes Obes Metab 2012, 14:112-120. 10.1111/j.1463-1326.2011.01483.x, 21812894.
41. Vrieze A, Holleman F, Zoetendal EG, de Vos WM, Hoekstra JB, Nieuwdorp M. The environment within: how gut microbiota may influence metabolism and body composition. Diabetologia 2010, 53:606-613. 10.1007/s00125-010-1662-7, 2830587, 20101384.
42. Diamant M, Blaak EE, de Vos WM. Do nutrient-gut-microbiota interactions play a role in human obesity, insulin resistance and type 2 diabetes?. Obes Rev 2011, 12:272-281. 10.1111/j.1467-789X.2010.00797.x, 20804522.
43. Esteve E, Ricart W, Fernandez-Real JM. Gut microbiota interactions with obesity, insulin resistance and type 2 diabetes: did gut microbiota co-evolve with insulin resistance?. Curr Opin Clin Nutr Metab Care 2011, 14:483-490. 10.1097/MCO.0b013e328348c06d, 21681087.
44. Timmerman HM, Koning CJ, Mulder L, Rombouts FM, Beynen AC. Monostrain, multistrain and multispecies probiotics-A comparison of functionality and efficacy. Int J Food Microbiol 2004, 96:219-233. 10.1016/j.ijfoodmicro.2004.05.012, 15454313.
45. Chapman CM, Gibson GR, Rowland I. Health benefits of probiotics: are mixtures more effective than single strains?. Eur J Nutr 2011, 50:1-17. 10.1007/s00394-010-0166-z, 21229254.
46. Hildebrandt MA, Hoffmann C, Sherrill-Mix SA, Keilbaugh SA, Hamady M, Chen YY, Knight R, Ahima RS, Bushman F, Wu GD. High-fat diet determines the composition of the murine gut microbiome independently of obesity. Gastroenterology 2009, 137:1716-1724. 10.1053/j.gastro.2009.08.042, 2770164, 19706296.
47. Niers LE, Timmerman HM, Rijkers GT, van Bleek GM, van Uden NO, Knol EF, Kapsenberg ML, Jimpen JL, Hoekstra MO. Identification of strong interleukin-10 inducing lactic acid bacteria which down-regulate T helper type 2 cytokines. Clin Exp Allergy 2005, 35:1481-1489. 10.1111/j.1365-2222.2005.02375.x, 16297146.
48. Groschwitz KR, Hogan SP. Intestinal barrier function: molecular regulation and disease pathogenesis. J Allergy Clin Immunol 2009, 124:3-20. quiz 1-2, 10.1016/j.jaci.2009.05.038, 19560575.
49. Lutgendorff F. Defending the barrier 2009, 396. Universiteit utrecht.
50. Ly NP, Litonjua A, Gold DR, Celedón JC. Gut microbiota, probiotics, and vitamin D: interrelated exposures influencing allergy, asthma, and obesity?. J Allergy Clin Immunol 2011, 127:1087-1094. 10.1016/j.jaci.2011.02.015, 3085575, 21419479.