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Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease

Italy120 participantsStarted 2022-04-20

Plain-language summary

Non-tuberculous mycobacterial (NTM) pulmonary disease (PD) is an emerging condition with heterogeneous manifestations from both the microbiological and the clinical point of view. Diagnostic and therapeutic guidelines are available but there are still unmet patients' and physicians' needs, including the exams to perform in the nutritional evaluation and intervention to improve health-related QoL and to control gastrointestinal side-effects during antimicrobial therapy, particularly in those with low body mass index and history of weight loss.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age greater than or equal to 18 years; * diagnosis of NTM-PD according to the BTS 2017 guidelines Exclusion Criteria: * severe renal failure, defined as a GFR (glomerular filtration rate) lower than 30ml / min; NYHA class IV; * severe liver failure, defined as Child-Pugh score class C; * active solid or haematological neoplasms; * having already received (currently or in the prior 6 months) antimicobacterial therapy; * severe immunosuppression; * inability to walk without help; * need for oxygen therapy at rest; * participation in other interventional experimental protocols with use of a medicinal product.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

BMI (body mass index)

Timeframe: baseline (NTM-PD diagnosis)

Trial details

NCT IDNCT05376280

SponsorUniversity of Milano Bicocca

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-04-30

Contact for this trial

Paola Faverio, MD

+390392334579 paola.faverio@gmail.com

View on ClinicalTrials.gov More Non-Tuberculous Mycobacterial Pneumonia trials