Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis

• Conditions: Cystic Fibrosis

• Registration Number: NCT03335202
• Lead Sponsor: University of Kiel

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.

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 Timeline

• Study Start: 2017-09-28
• Study First Submitted: 2017-09-28
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-11-17
• Primary Completion: 2019-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
respiratory microbiome	24 weeks	abundance \[operational taxonomic units\]
intestinal microbiome	24 weeks	abundance \[operational taxonomic units\]

Secondary Outcome Measures

Name	Time	Method
Forced Exspiratory Volume FEV1 [%pred]	24 weeks	performed by bodyplethmograph
weight (kg)	24 weeks	for children, height (cm) is also recorded
Quality of life [score]	24 weeks	Kiel Questionnaire Kiel-Q \[score 0-100, higher scores indicating hetter Quality of Life\]

Trial Locations

Locations (1)

Klinik für Innere Medizin I, UKSH KIel; 🇩🇪 Kiel, Schleswig Holstein, Germany