Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03335202

Enrollment

Registered

2017-11-07

Start date

2017-09-28

Completion date

2020-09-30

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

respiratory and intestinal microbiome, antibiotic therapy, cftr modifier, diversity

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.

Interventions

DIAGNOSTIC_TESTanalysis of microbiome

microbial profiling by next generation sequencing

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
respiratory microbiome	24 weeks	abundance \[operational taxonomic units\]
intestinal microbiome	24 weeks	abundance \[operational taxonomic units\]

Secondary

Measure	Time frame	Description
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	Cystic Fibrosis Questionnaire Revised CFQ-R \[score 0-100, higher scores indicating better Quality of Life\]

Countries

Germany

Contacts

Primary ContactIngrid CF Bobis, MD

ingrid.bobis@uksh.de+49-1578-8209311

Backup ContactAndre Franke, PhD

a.franke@mucosa.de+49-431-500-15110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026