Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis

NCT03335202 | Unknown

• 1 other identifier: B495/16
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

respiratory and intestinal microbiome; antibiotic therapy; cftr modifier; diversity

Outcome Measures

Primary Outcomes (2)

• respiratory microbiome

  abundance \[operational taxonomic units\]

  24 weeks

• intestinal microbiome

  abundance \[operational taxonomic units\]

  24 weeks

Secondary Outcomes (4)

• Forced Exspiratory Volume FEV1 [%pred]

  24 weeks

• weight (kg)

  24 weeks

• Quality of life [score]

  24 weeks

• Quality of life [score]

  24 weeks

Study Arms (1)

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

Interventions

analysis of microbiome DIAGNOSTIC_TEST

microbial profiling by next generation sequencing

cf patients at the cf centre Kiel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Kiel: lead

Study Sites (1)

Klinik für Innere Medizin I, UKSH KIel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sputum, throat swab and stool

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Ingrid CF Bobis, MD

  Klinik für Innere Medizin I, UKSH Kiel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid CF Bobis, MD

CONTACT

+49-1578-8209311; ingrid.bobis@uksh.de

Andre Franke, PhD

CONTACT

+49-431-500-15110; a.franke@mucosa.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med., Oberärztin für Pneumologie, Head of Adult CF Centre UKSH Kiel, Klinik für Innere Medizin I UKSH Kiel

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: November 7, 2017
• Study Start: September 28, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2020
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)