Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03335202
• Other study ID #: B495/16
• Status: Recruiting
• Phase: N/A
• First received: September 28, 2017
• Last updated: November 15, 2017
• Start date: September 28, 2017
• Est. completion date: September 2020

Study information

• Verified date: November 2017
• Source: University of Kiel
• Contact: Ingrid CF Bobis, MD
• Phone: +49-1578-8209311
• Email: ingrid.bobis[@]uksh.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Diagnostic Test:
• analysis of microbiome
microbial profiling by next generation sequencing

Locations

Country	Name	City	State
Germany	Klinik für Innere Medizin I, UKSH KIel	Kiel	Schleswig Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory microbiome	abundance [operational taxonomic units]	24 weeks
Primary	intestinal microbiome	abundance [operational taxonomic units]	24 weeks
Secondary	Forced Exspiratory Volume FEV1 [%pred]	performed by bodyplethmograph	24 weeks
Secondary	weight (kg)	for children, height (cm) is also recorded	24 weeks
Secondary	Quality of life [score]	Cystic Fibrosis Questionnaire Revised CFQ-R [score 0-100, higher scores indicating better Quality of Life]	24 weeks
Secondary	Quality of life [score]	Kiel Questionnaire Kiel-Q [score 0-100, higher scores indicating hetter Quality of Life]	24 weeks