Cystic FibrosisNCT03335202
Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by University of Kiel at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- analysis of microbiome
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 28 Sep 2017to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult cf patients treated in Adult Cystic Fibrosis Center, Klinik für Innere Medizin I, UKSH Kiel
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Innere Medizin I, UKSH KIel
Kiel, Schleswig-Holstein, 24105
Ingrid CF Bobis, MD, +49-1578-8209311, ingrid.bobis@uksh.de
Andre Franke, PhD, +49-431-500-15110, a.franke@mucosa.de
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- analysis of microbiome
- Keywords
- respiratory and intestinal microbiome, antibiotic therapy, cftr modifier, diversity
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of microbiomeDiagnostic test
microbial profiling by next generation sequencing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: analysis of microbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory microbiome
abundance [operational taxonomic units]
Measured: 24 weeks
intestinal microbiome
abundance [operational taxonomic units]
Measured: 24 weeks
Secondary outcomes (4)
Forced Exspiratory Volume FEV1 [%pred]
performed by bodyplethmograph
Measured: 24 weeks
weight (kg)
for children, height (cm) is also recorded
Measured: 24 weeks
Quality of life [score]
Cystic Fibrosis Questionnaire Revised CFQ-R [score 0-100, higher scores indicating better Quality of Life]
Measured: 24 weeks
Quality of life [score]
Kiel Questionnaire Kiel-Q [score 0-100, higher scores indicating hetter Quality of Life]
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start28 Sep 2017
- Primary completionSep 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Bobis, University of Kiel
- Investigators
- Ingrid CF Bobis, MD, Principal investigator, Klinik für Innere Medizin I, UKSH Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335202
- Sponsor's protocol ID
- B495/16
- Status last verified
- Nov 2017
- First submitted
- 28 Sep 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03335202
- Acronym / sponsor ID
- B495/16
- Conditions
- Cystic Fibrosis
- Keywords
- respiratory and intestinal microbiome, antibiotic therapy, cftr modifier, diversity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of KielUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cf patients at the cf centre Kiel | – | Diagnostic Test: analysis of microbiomemicrobiome of cf patients at the cf centre Kiel will be analyzed and correlated to standard cf care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult cf patients treated in Adult Cystic Fibrosis Center, Klinik für Innere Medizin I, UKSH Kiel
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analysis of microbiomemicrobial profiling by next generation sequencing | Diagnostic test | cf patients at the cf centre Kiel |
Primary outcome
respiratory microbiome
Time frame: 24 weeks
abundance [operational taxonomic units]
intestinal microbiome
Time frame: 24 weeks
abundance [operational taxonomic units]
4 secondary outcomes
Forced Exspiratory Volume FEV1 [%pred]
Time frame: 24 weeks
weight (kg)
Time frame: 24 weeks
Quality of life [score]
Time frame: 24 weeks
Quality of life [score]
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid CF Bobis, MD principal investigator
Klinik für Innere Medizin I, UKSH Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University of Kiel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingrid CF Bobis, MD (+49-1578-8209311, ingrid.bobis@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory microbiome (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.