Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis

November 15, 2017 updated by: Ingrid Bobis, University of Kiel
Respiratory und intestinal microbiome will bei analyzed during a period of 6 months. In a retrospective analysis it will be looked for correlations between microbiome and cf therapy (e.g. inhaled and systemic antibiotics, cftr modifiers, proton pump Inhibitors, enzymes, nutritional habits), clinical status and self reported outcome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

DNA will be isolated from sputum, throat swabs and stool samples and used for the generation of microbial profiles. Both bacterial and fungal profiles will be analyzed by next generation sequencing.

Clinical outcome parameters (lung function test, weight, calprotectin, elastase, blood parameters, self reported outcome) will be recorded and analyzed along with medication.

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

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

Study Locations

  • Germany
    • Schleswig Holstein
      • Kiel, Schleswig Holstein, Germany, 24105
        • Recruiting
        • Klinik für Innere Medizin I, UKSH KIel
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Stefan Schreiber, MD
        • Sub-Investigator:
          • Burkhard Bewig, MD
        • Sub-Investigator:
          • Andre Franke, PhD
        • Sub-Investigator:
          • Corinna Bang, PhD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adult cf patients treated in Adult Cystic Fibrosis Center, Klinik für Innere Medizin I, UKSH Kiel

Description

Inclusion Criteria:

  • subject has confirmed diagnosis of cystic fibrosis (sweat chloride >60mmol/l and/or 2 mutations in the cftr gene known to cause cystic fibrosis)
  • subject is able to perform informed consent

Exclusion Criteria:

  • inability to give informed consent
  • antibiotic therapy in the last 4 weeks prior to study start (exception: long term azithromycin therapy, long term antistaphylococcal therapy, long term inhaled antibiotics)

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: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cf patients at the cf centre Kiel
microbiome of cf patients at the cf centre Kiel will be analyzed and correlated to standard cf care.
Diagnostic test: analysis of microbiome
microbial profiling by next generation sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory microbiome
Time Frame: 24 weeks
abundance [operational taxonomic units]
24 weeks
intestinal microbiome
Time Frame: 24 weeks
abundance [operational taxonomic units]
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Exspiratory Volume FEV1 [%pred]
Time Frame: 24 weeks
performed by bodyplethmograph
24 weeks
weight (kg)
Time Frame: 24 weeks
for children, height (cm) is also recorded
24 weeks
Quality of life [score]
Time Frame: 24 weeks
Cystic Fibrosis Questionnaire Revised CFQ-R [score 0-100, higher scores indicating better Quality of Life]
24 weeks
Quality of life [score]
Time Frame: 24 weeks
Kiel Questionnaire Kiel-Q [score 0-100, higher scores indicating hetter Quality of Life]
24 weeks

Collaborators and Investigators

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

Sponsor

University of Kiel

Investigators

  • Principal Investigator: Ingrid CF Bobis, MD, Klinik für Innere Medizin I, UKSH KIel

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)

September 28, 2017

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

September 28, 2017

First Submitted That Met QC Criteria

November 3, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B495/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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