Respiratory Microbiome in COPD and Associated Inmune Response.
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Unknown status
CT.gov ID
NCT03321708
Collaborator
(none)
50
1
33
1.5
Study Details
Study Description
Brief Summary
Hypothesis:
COPD patients with frequent exacerbations have different pulmonary and systemic immune response than COPD patients without frequent exacerbations and this is related to their microbiome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
The objective of this project is to determine the pulmonary microbiome and its relationship with the pulmonary and systemic inmune response in COPD patients with frequent (FE) and non frequent exacerbations (NE).
- The pulmonary immune response.
-The role of mucins, antimicrobial peptides (AMPs), Matrix metalloproteinases (MMPs) and Toll-like receptors (TLRs) as lung defense mechanisms and their possible relationship with the microbiome in COPD and FE patients.
- The systemic immune response. -The pulmonary and blood inflammatory response and circulating bacterial products as markers of the systemic immune response.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Respiratory Microbiome in COPD. Relationship With Systemic and Pulmonary Inmune Response.
Actual Study Start Date
:
Mar 1, 2016
Anticipated Primary Completion Date
:
Mar 1, 2018
Anticipated Study Completion Date
:
Dec 1, 2018
Outcome Measures
Primary Outcome Measures
- Relationship of pulmonary microbiome with the immune response (local and systemic). [6 months]
Microbiome will be determined by using 16s RNA techniques. The inmune response will be studied with ELISA kits.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Diagnosis of COPD according to national and international guidelines.
-
Clinical stability (8 previous weeks).
-
Signature of informed consent.
Exclusion Criteria:
-
Antibiotic treatment the previous 8 weeks.
-
Other lung diseases.
-
Active neoplasic disease.
-
Terminal concomitant disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oriol Sibila Vidal | Barcelona | Spain | 08041 |
Sponsors and Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
- Principal Investigator: Oriol Sibila Vidal, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Documents (Full-Text)
None provided.More Information
Publications
- Clarke TB, Davis KM, Lysenko ES, Zhou AY, Yu Y, Weiser JN. Recognition of peptidoglycan from the microbiota by Nod1 enhances systemic innate immunity. Nat Med. 2010 Feb;16(2):228-31. doi: 10.1038/nm.2087. Epub 2010 Jan 17.
- Fujisawa T, Chang MM, Velichko S, Thai P, Hung LY, Huang F, Phuong N, Chen Y, Wu R. NF-κB mediates IL-1β- and IL-17A-induced MUC5B expression in airway epithelial cells. Am J Respir Cell Mol Biol. 2011 Aug;45(2):246-52. doi: 10.1165/rcmb.2009-0313OC. Epub 2010 Oct 8.
- Harder J, Meyer-Hoffert U, Teran LM, Schwichtenberg L, Bartels J, Maune S, Schröder JM. Mucoid Pseudomonas aeruginosa, TNF-alpha, and IL-1beta, but not IL-6, induce human beta-defensin-2 in respiratory epithelia. Am J Respir Cell Mol Biol. 2000 Jun;22(6):714-21.
- Kirkham S, Kolsum U, Rousseau K, Singh D, Vestbo J, Thornton DJ. MUC5B is the major mucin in the gel phase of sputum in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2008 Nov 15;178(10):1033-9. doi: 10.1164/rccm.200803-391OC. Epub 2008 Sep 5.
- Medzhitov R. Toll-like receptors and innate immunity. Nat Rev Immunol. 2001 Nov;1(2):135-45. Review.
- Millares L, Marin A, Garcia-Aymerich J, Sauleda J, Belda J, Monsó E; PAC-COPD Study Group. Specific IgA and metalloproteinase activity in bronchial secretions from stable chronic obstructive pulmonary disease patients colonized by Haemophilus influenzae. Respir Res. 2012 Dec 11;13:113. doi: 10.1186/1465-9921-13-113.
- Mizgerd JP. Respiratory infection and the impact of pulmonary immunity on lung health and disease. Am J Respir Crit Care Med. 2012 Nov 1;186(9):824-9. doi: 10.1164/rccm.201206-1063PP. Epub 2012 Jul 12.
- Parameswaran GI, Sethi S, Murphy TF. Effects of bacterial infection on airway antimicrobial peptides and proteins in COPD. Chest. 2011 Sep;140(3):611-617. doi: 10.1378/chest.10-2760. Epub 2011 Feb 24.
- Roy MG, Livraghi-Butrico A, Fletcher AA, McElwee MM, Evans SE, Boerner RM, Alexander SN, Bellinghausen LK, Song AS, Petrova YM, Tuvim MJ, Adachi R, Romo I, Bordt AS, Bowden MG, Sisson JH, Woodruff PG, Thornton DJ, Rousseau K, De la Garza MM, Moghaddam SJ, Karmouty-Quintana H, Blackburn MR, Drouin SM, Davis CW, Terrell KA, Grubb BR, O'Neal WK, Flores SC, Cota-Gomez A, Lozupone CA, Donnelly JM, Watson AM, Hennessy CE, Keith RC, Yang IV, Barthel L, Henson PM, Janssen WJ, Schwartz DA, Boucher RC, Dickey BF, Evans CM. Muc5b is required for airway defence. Nature. 2014 Jan 16;505(7483):412-6. doi: 10.1038/nature12807. Epub 2013 Dec 8.
- Yang D, Biragyn A, Hoover DM, Lubkowski J, Oppenheim JJ. Multiple roles of antimicrobial defensins, cathelicidins, and eosinophil-derived neurotoxin in host defense. Annu Rev Immunol. 2004;22:181-215.
Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT03321708
Other Study ID Numbers:
- IIBSP-MIC-2015-57
First Posted:
Oct 26, 2017
Last Update Posted:
Oct 26, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: