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Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis

NCT ID: NCT03335202

Last Updated: 2017-11-17

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-28

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cystic Fibrosis

Keywords

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respiratory and intestinal microbiome antibiotic therapy cftr modifier diversity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

analysis of microbiome

Intervention Type DIAGNOSTIC_TEST

microbial profiling by next generation sequencing

Interventions

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analysis of microbiome

microbial profiling by next generation sequencing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kiel

OTHER

Sponsor Role lead

Responsible Party

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Ingrid Bobis

Dr. med., Oberärztin für Pneumologie, Head of Adult CF Centre UKSH Kiel, Klinik für Innere Medizin I UKSH Kiel

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingrid CF Bobis, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Innere Medizin I, UKSH Kiel

Locations

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Klinik für Innere Medizin I, UKSH KIel

Kiel, Schleswig-Holstein, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ingrid CF Bobis, MD

Role: CONTACT

Phone: +49-1578-8209311

Email: [email protected]

Andre Franke, PhD

Role: CONTACT

Phone: +49-431-500-15110

Email: [email protected]

Facility Contacts

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Ingrid CF Bobis, MD

Role: primary

Andre Franke, PhD

Role: backup

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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B495/16

Identifier Type: -

Identifier Source: org_study_id