An observational study in Cystic Fibrosis (CF), Mucoviscidosis and Non-Tuberculous Mycobacteria, sponsored by Research Center Borstel. Recruiting at 2 sites in Germany. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Research Center Borstel · Observational
This multicenter, non-interventional case-control study investigates whether household environmental reservoirs, particularly water systems, are associated with non-tuberculous mycobacterial (NTM) infections in people with cystic fibrosis (CF). Environmental samples from the homes of CF patients with and without NTM infection will be analyzed and genetically compared with available clinical isolates, alongside assessment of environmental risk factors, to improve understanding of exposure pathways and inform future prevention strategies.
This multicenter, non-interventional case-control study investigates whether domestic environmental reservoirs-particularly household water systems-contribute to non-tuberculous mycobacterial (NTM) infections in people with cystic fibrosis (CF). Approximately 120 CF patients from several centers in Germany will be enrolled, including 60 patients with a current or previous pulmonary NTM infection and 60 CF patients without known NTM infection as controls.
Environmental samples (water, dust, and soil) will be collected from participants' households and analyzed for the presence of NTM using culture-based methods, PCR, and whole-genome sequencing. These findings will be compared between case and control households, and genetic similarity between environmental NTM isolates and available clinical isolates from the same patients will be assessed. In addition, standardized questionnaires will capture environmental and behavioral risk factors associated with NTM occurrence.
The study is purely observational and relies on clinical data and isolates obtained through routine CF care, with no additional medical procedures for participants. Over a follow-up period of up to three years, newly occurring NTM infections in initially unaffected patients will be documented. The results aim to improve understanding of environmental exposure risks for NTM in CF and to provide evidence for future prevention strategies and potential guideline recommendations.
1,619 studies on the registry are indexed under Cystic Fibrosis; 199 are open to participants now.
This study's planned enrollment of 120 is above the median of 85 across 503 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Research Center Borstel is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population comprises 120 individuals with a confirmed diagnosis of cystic fibrosis recruited from multiple centers in Germany. Participants include both adults and minors (with consent from legal guardians) and are divided equally into a case group of patients with a current or prior pulmonary NTM infection and a control group of patients without a known history of NTM infection. All participants provide written informed consent, and clinical data and isolates are obtained exclusively from routine care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
60 CF patients with a confirmed current or previously diagnosed NTM infection (according to ATS/IDSA criteria)
Other: Multi-modal NTM diagnostic including PCR, WGS, culture
60 CF patients without a known or previously diagnosed NTM infection (according to ATS/IDSA criteria)
Other: Multi-modal NTM diagnostic including PCR, WGS, culture
Environmental samples from participants' households (e.g., water, dust, and soil) will be collected and tested for the presence of NTM. Analyses will be performed using PCR, culture-based methods, whole-genome sequencing (WGS), and subsequent bioinformatic analyses. In addition, available clinical NTM isolates from previous or future routine diagnostics will be included. If genomic sequencing has not yet been performed for these isolates, retrospective molecular genetic analysis (e.g., by WGS) will be conducted within the study to enable comparison with environmental isolates.
Prevalence of NTM in environmental samples
Proportion of households of CF patients with and without NTM infection in which at least one (clinically relevant) NTM is detected in environmental samples (water, dust, soil).
Time frame: December 2030
Difference in NTM prevalence between case and control groups
Statistically significant difference in the frequency of NTM detection (clinically relevant and/or all NTM) in environmental samples between case group and control group.
Time frame: December 2030
Genetic concordance between environmental and patient isolates
Evidence of genetic relatedness (e.g., cgMLST clustering) between NTM detected in the household environment and clinical isolates from the same individual.
Time frame: December 2030
Characterization of NTM species from environmental samples
Identification and taxonomic classification of NTM isolates using WGS, including typing (e.g., subspecies assignment for M. avium).
Time frame: December 2030
Identification of environmental and behavioral factors associated with NTM detection
Determination of significant risk factors (e.g., use of specific water sources, pet ownership, hygiene practices) based on questionnaire data and multivariable analyses.
Time frame: December 2030
Long-term outcomes (control group only)
Proportion of patients without an initial NTM infection who develop a clinically relevant NTM infection during the follow-up period (up to 30 months), potentially in association with prior detection of NTM in the household environment.
Time frame: December 2030
Plan to share: No — IPD will be shared upon reasonable request via contacting the prinicpal investigator.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2028, 34 months after the start.
Of 228 non-industry observational studies under Cystic Fibrosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 89. This study's planned 34 months is below that.
Counting every sponsor, half of 243 studies reached it within 41 months; a quarter within 19 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Research Center Borstel