Low Grade Inflammation, Gut Microbiota and Barrier Function in Elderly Humans
NCT ID: NCT01218165
Last Updated: 2011-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
48 participants
INTERVENTIONAL
2010-05-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control Group
without intervention
Control Group
without intervention
Intervention Group
This group receives a probiotic drink daily for 6 week.
Probiotic drink
This group receives a probiotic drink daily for 6 week.
Interventions
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Probiotic drink
This group receives a probiotic drink daily for 6 week.
Control Group
without intervention
Eligibility Criteria
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Inclusion Criteria
* Body mass index: 22-34,9 kg/m²
* non-smokers
Intervention trial:
* hsCRP \> 1 mg/L (Screening blood test)
* normal blood count (Screening blood test)
* normal ALAT, ASAT and serum creatinine levels (Screening blood test)
Exclusion Criteria
* any major organ disease, including neoplastic diseases.
* intake of antibiotics within the last 6 weeks
* chronic therapy with analgetics (incl. acetylsalicylic acid)
* chronic therapy with proton pump inhibitors
* regular intake of probiotic bacteria products within the last 3 weeks
* chronic anti-inflammatory therapy with NSARs or previous therapy within the last 20 days
* subjects with expected non-compliance to protocol guidelines
* subjects that participate in other trials
65 Years
85 Years
MALE
Yes
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Luzia Valentini
Research Scientist
Principal Investigators
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Luzia Valentini, Doctor
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Herbert Lochs, Professor
Role: PRINCIPAL_INVESTIGATOR
Medical University of Innsbruck
Jörg-Dieter Schulzke, Professor
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Stefan Bereswill, Professor
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Alexander Swidsinski, Doctor
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Countries
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References
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Ballantyne CM, Nambi V. Markers of inflammation and their clinical significance. Atheroscler Suppl. 2005 May;6(2):21-9. doi: 10.1016/j.atherosclerosissup.2005.02.005.
Pearson TA, Mensah GA, Alexander RW, Anderson JL, Cannon RO 3rd, Criqui M, Fadl YY, Fortmann SP, Hong Y, Myers GL, Rifai N, Smith SC Jr, Taubert K, Tracy RP, Vinicor F; Centers for Disease Control and Prevention; American Heart Association. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation. 2003 Jan 28;107(3):499-511. doi: 10.1161/01.cir.0000052939.59093.45. No abstract available.
Imhof A, Frohlich M, Loewel H, Helbecque N, Woodward M, Amouyel P, Lowe GD, Koenig W. Distributions of C-reactive protein measured by high-sensitivity assays in apparently healthy men and women from different populations in Europe. Clin Chem. 2003 Apr;49(4):669-72. doi: 10.1373/49.4.669. No abstract available.
Lannergard A, Friman G, Ewald U, Lind L, Larsson A. Serum amyloid A (SAA) protein and high-sensitivity C-reactive protein (hsCRP) in healthy newborn infants and healthy young through elderly adults. Acta Paediatr. 2005 Sep;94(9):1198-202. doi: 10.1111/j.1651-2227.2005.tb02074.x.
Libby P, Okamoto Y, Rocha VZ, Folco E. Inflammation in atherosclerosis: transition from theory to practice. Circ J. 2010 Feb;74(2):213-20. doi: 10.1253/circj.cj-09-0706. Epub 2010 Jan 9.
Pradhan AD, Manson JE, Rifai N, Buring JE, Ridker PM. C-reactive protein, interleukin 6, and risk of developing type 2 diabetes mellitus. JAMA. 2001 Jul 18;286(3):327-34. doi: 10.1001/jama.286.3.327.
Griffin WS. Inflammation and neurodegenerative diseases. Am J Clin Nutr. 2006 Feb;83(2):470S-474S. doi: 10.1093/ajcn/83.2.470S.
Kimble RB, Matayoshi AB, Vannice JL, Kung VT, Williams C, Pacifici R. Simultaneous block of interleukin-1 and tumor necrosis factor is required to completely prevent bone loss in the early postovariectomy period. Endocrinology. 1995 Jul;136(7):3054-61. doi: 10.1210/endo.136.7.7789332.
Pirlich M, Norman K, Lochs H, Bauditz J. Role of intestinal function in cachexia. Curr Opin Clin Nutr Metab Care. 2006 Sep;9(5):603-6. doi: 10.1097/01.mco.0000241671.09676.d8.
D'Souza T, Sherman-Baust CA, Poosala S, Mullin JM, Morin PJ. Age-related changes of claudin expression in mouse liver, kidney, and pancreas. J Gerontol A Biol Sci Med Sci. 2009 Nov;64(11):1146-53. doi: 10.1093/gerona/glp118. Epub 2009 Aug 19.
Saltzman JR, Kowdley KV, Perrone G, Russell RM. Changes in small-intestine permeability with aging. J Am Geriatr Soc. 1995 Feb;43(2):160-4. doi: 10.1111/j.1532-5415.1995.tb06382.x.
Beaumont DM, Cobden I, Sheldon WL, Laker MF, James OF. Passive and active carbohydrate absorption by the ageing gut. Age Ageing. 1987 Sep;16(5):294-300. doi: 10.1093/ageing/16.5.294.
Guarner F. Enteric flora in health and disease. Digestion. 2006;73 Suppl 1:5-12. doi: 10.1159/000089775. Epub 2006 Feb 8.
Ordovas JM, Mooser V. Metagenomics: the role of the microbiome in cardiovascular diseases. Curr Opin Lipidol. 2006 Apr;17(2):157-61. doi: 10.1097/01.mol.0000217897.75068.ba.
Turnbaugh PJ, Ridaura VK, Faith JJ, Rey FE, Knight R, Gordon JI. The effect of diet on the human gut microbiome: a metagenomic analysis in humanized gnotobiotic mice. Sci Transl Med. 2009 Nov 11;1(6):6ra14. doi: 10.1126/scitranslmed.3000322.
Degens H. Age-related skeletal muscle dysfunction: causes and mechanisms. J Musculoskelet Neuronal Interact. 2007 Jul-Sep;7(3):246-52.
Hamer M, Molloy GJ. Association of C-reactive protein and muscle strength in the English Longitudinal Study of Ageing. Age (Dordr). 2009 Sep;31(3):171-7. doi: 10.1007/s11357-009-9097-0. Epub 2009 May 23.
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Swidsinski A, Weber J, Loening-Baucke V, Hale LP, Lochs H. Spatial organization and composition of the mucosal flora in patients with inflammatory bowel disease. J Clin Microbiol. 2005 Jul;43(7):3380-9. doi: 10.1128/JCM.43.7.3380-3389.2005.
Swidsinski A. Standards for bacterial identification by fluorescence In situ hybridization within eukaryotic tissue using ribosomal rRNA-based probes. Inflamm Bowel Dis. 2006 Aug;12(8):824-6; author reply 826-7. doi: 10.1097/00054725-200608000-00018. No abstract available.
Puthoff ML, Janz KF, Nielson D. The relationship between lower extremity strength and power to everday walking behaviors in older adults with functional limitations. J Geriatr Phys Ther. 2008;31(1):24-31. doi: 10.1519/00139143-200831010-00005.
Other Identifiers
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EA1/062/10
Identifier Type: -
Identifier Source: org_study_id