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Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Cystic Fibrosis Diagnostic Test: analysis of microbiome

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.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
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
microbial profiling by next generation sequencing




Primary Outcome Measures :
  1. respiratory microbiome [ Time Frame: 24 weeks ]
    abundance [operational taxonomic units]

  2. intestinal microbiome [ Time Frame: 24 weeks ]
    abundance [operational taxonomic units]


Secondary Outcome Measures :
  1. Forced Exspiratory Volume FEV1 [%pred] [ Time Frame: 24 weeks ]
    performed by bodyplethmograph

  2. weight (kg) [ Time Frame: 24 weeks ]
    for children, height (cm) is also recorded

  3. Quality of life [score] [ Time Frame: 24 weeks ]
    Cystic Fibrosis Questionnaire Revised CFQ-R [score 0-100, higher scores indicating better Quality of Life]

  4. Quality of life [score] [ Time Frame: 24 weeks ]
    Kiel Questionnaire Kiel-Q [score 0-100, higher scores indicating hetter Quality of Life]


Biospecimen Retention:   Samples With DNA
Sputum, throat swab and stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult cf patients treated in Adult Cystic Fibrosis Center, Klinik für Innere Medizin I, UKSH Kiel
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335202


Contacts
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Contact: Ingrid CF Bobis, MD +49-1578-8209311 ingrid.bobis@uksh.de
Contact: Andre Franke, PhD +49-431-500-15110 a.franke@mucosa.de

Locations
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Germany
Klinik für Innere Medizin I, UKSH KIel Recruiting
Kiel, Schleswig Holstein, Germany, 24105
Contact: Ingrid CF Bobis, MD    +49-1578-8209311    ingrid.bobis@uksh.de   
Contact: Andre Franke, PhD    +49-431-500-15110    a.franke@mucosa.de   
Sub-Investigator: Stefan Schreiber, MD         
Sub-Investigator: Burkhard Bewig, MD         
Sub-Investigator: Andre Franke, PhD         
Sub-Investigator: Corinna Bang, PhD         
Sponsors and Collaborators
University of Kiel
Investigators
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Principal Investigator: Ingrid CF Bobis, MD Klinik für Innere Medizin I, UKSH Kiel
  Study Documents (Full-Text)

Documents provided by Ingrid Bobis, University of Kiel:
Study Protocol  [PDF] September 28, 2017

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Responsible Party: Ingrid Bobis, Dr. med., Oberärztin für Pneumologie, Head of Adult CF Centre UKSH Kiel, Klinik für Innere Medizin I UKSH Kiel, University of Kiel
ClinicalTrials.gov Identifier: NCT03335202    
Other Study ID Numbers: B495/16
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Ingrid Bobis, University of Kiel:
respiratory and intestinal microbiome
antibiotic therapy
cftr modifier
diversity
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases