Actively Recruiting
Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households: A Case-control Study of Exposure Risk at Home
Led by Research Center Borstel · Updated on 2026-01-27
120
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether household environmental sources, especially water systems, are linked to non-tuberculous mycobacterial (NTM) infections in people with cystic fibrosis (CF). This observational case-control study includes about 120 CF patients from several centers in Germany, half with a current or past NTM lung infection and half without. The study aims to better understand how people with CF might be exposed to NTM at home and guide future prevention strategies. Environmental samples such as water, dust, and soil will be collected from participants' homes and tested for NTM using methods like culture, PCR, and whole-genome sequencing. These results will be compared between households of patients with and without NTM infections. Researchers will also compare environmental NTM to clinical isolates from the same patients and gather information on environmental and behavioral risk factors through questionnaires. The study is non-interventional and relies on data and samples collected during routine CF care. Participants will be followed for up to three years to document any new NTM infections in those initially without infection. The research team will assess the prevalence of NTM in home environments, differences between groups, and genetic similarities between environmental and patient samples. The study also looks at long-term outcomes and helps identify risk factors associated with NTM presence. There are no extra medical procedures for participants beyond routine care.
CONDITIONS
Brief Title
Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households: A Case-control Study of Exposure Risk at Home
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of cystic fibrosis (CF)
- No age restriction, including minors with consent from legal guardians
- Written informed consent to participate in the study, or consent from a legal guardian for minors
- For those with NTM infection: diagnosis according to ATS/IDSA criteria and availability of a clinical NTM isolate
You will not qualify if you...
- Lack of capacity to provide informed consent
- Refusal to participate in the study
- Withdrawal of informed consent during the study period
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Initial assessment period
Environmental samples such as water, dust, and soil are collected from participants' households and tested for non-tuberculous mycobacteria using PCR, culture, and whole-genome sequencing. Available clinical isolates from routine care are also analyzed for comparison.
1 to 2 visits for sample collection and questionnaires
Duration - Up to 3 years
Participants are observed over time for the occurrence of new NTM infections and environmental exposures are monitored through questionnaires and routine clinical data.
Periodic follow-up assessments depending on clinical care and study schedule
Trial Site Locations
Total: 2 locations
1
National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center
Borstel, Schleswig-Holstein, Germany, 23845
Actively Recruiting
2
Klinik für Pneumologie, Universitätsklinikum Essen
Essen, Germany
Not Yet Recruiting
Research Team
M
Margo Diricks, PhD
N
Niklas Koehler, Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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