Assessing Nutrition in Patients with Non-Tuberculous Mycobacterial Pneumonia
Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease: an Exploratory Study
This study looks at the nutrition of people with non-tuberculous mycobacterial pneumonia to see how their health and weight compare to others and how treatment might affect their overall well-being.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 1 site (Monza, MB) |
| Trial ID | NCT05376280 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the nutritional status of patients diagnosed with non-tuberculous mycobacterial pulmonary disease (NTM-PD). It involves a multicenter cohort design where participants will undergo two pneumological visits and multiple nutritional assessments over a six-month period. The study will measure various health indicators, including body mass index, oxygen saturation, and physical performance, to determine the prevalence of underweight individuals compared to the general population. The goal is to understand how targeted antibiotic therapy may impact nutritional status and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with non-tuberculous mycobacterial pulmonary disease.
Not a fit: Patients with severe renal or liver failure, active malignancies, or those requiring oxygen therapy at rest may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional interventions for patients with NTM-PD, enhancing their quality of life during treatment.
How similar studies have performed: While there is limited data on similar studies specifically targeting nutritional assessment in NTM-PD, the approach of evaluating nutritional status in chronic pulmonary conditions has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Monza, MB
- IRCCS San Gerardo dei Tintori — Monza, Mb, Italy (Recruiting)
Study contacts
- Study coordinator: Paola Faverio, MD
- Email: paola.faverio@gmail.com
- Phone: +390392334579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.