Actively Recruiting

All Genders
ID07369414

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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