Respiratory Microbiome in COPD and Associated Inmune Response.

October 23, 2017 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Respiratory Microbiome in COPD. Relationship With Systemic and Pulmonary Inmune Response.

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.

Study Overview

Status

Unknown

Conditions

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).

  1. 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.

  2. The systemic immune response. -The pulmonary and blood inflammatory response and circulating bacterial products as markers of the systemic immune response.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Oriol Sibila Vidal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Clinically stable COPD patients.

Description

Inclusion Criteria:

  1. Diagnosis of COPD according to national and international guidelines.
  2. Clinical stability (8 previous weeks).
  3. Signature of informed consent.

Exclusion Criteria:

  1. Antibiotic treatment the previous 8 weeks.
  2. Other lung diseases.
  3. Active neoplasic disease.
  4. Terminal concomitant disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship of pulmonary microbiome with the immune response (local and systemic).
Time Frame: 6 months
Microbiome will be determined by using 16s RNA techniques. The inmune response will be studied with ELISA kits.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 23, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 26, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-MIC-2015-57

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Disease (COPD), Chronic Obstructive

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe