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Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT03335202
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Ingrid Bobis, University of Kiel

Tracking Information
First Submitted Date September 28, 2017
First Posted Date November 7, 2017
Last Update Posted Date November 17, 2017
Actual Study Start Date September 28, 2017
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 3, 2017)
  • respiratory microbiome [ Time Frame: 24 weeks ]
    abundance [operational taxonomic units]
  • intestinal microbiome [ Time Frame: 24 weeks ]
    abundance [operational taxonomic units]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 15, 2017)
  • Forced Exspiratory Volume FEV1 [%pred] [ Time Frame: 24 weeks ]
    performed by bodyplethmograph
  • weight (kg) [ Time Frame: 24 weeks ]
    for children, height (cm) is also recorded
  • Quality of life [score] [ Time Frame: 24 weeks ]
    Cystic Fibrosis Questionnaire Revised CFQ-R [score 0-100, higher scores indicating better Quality of Life]
  • Quality of life [score] [ Time Frame: 24 weeks ]
    Kiel Questionnaire Kiel-Q [score 0-100, higher scores indicating hetter Quality of Life]
Original Secondary Outcome Measures
 (submitted: November 3, 2017)
  • Forced Exspiratory Volume FEV1 [%pred] [ Time Frame: 24 weeks ]
    performed by bodyplethmograph
  • weight (kg) [ Time Frame: 24 weeks ]
    for children, height (cm) is also recorded
  • Quality of life [ Time Frame: 24 weeks ]
    Cystic Fibrosis Questionnaire Revised CFQ-R [score]
  • Quality of life [ Time Frame: 24 weeks ]
    Kiel Questionnaire Kiel-Q [score]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis
Official Title Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Sputum, throat swab and stool
Sampling Method Probability Sample
Study Population adult cf patients treated in Adult Cystic Fibrosis Center, Klinik für Innere Medizin I, UKSH Kiel
Condition Cystic Fibrosis
Intervention Diagnostic Test: analysis of microbiome
microbial profiling by next generation sequencing
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: analysis of microbiome
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 3, 2017)
45
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ingrid CF Bobis, MD +49-1578-8209311 ingrid.bobis@uksh.de
Contact: Andre Franke, PhD +49-431-500-15110 a.franke@mucosa.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03335202
Other Study ID Numbers B495/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ingrid Bobis, University of Kiel
Study Sponsor University of Kiel
Collaborators Not Provided
Investigators
Principal Investigator: Ingrid CF Bobis, MD Klinik für Innere Medizin I, UKSH Kiel
PRS Account University of Kiel
Verification Date November 2017