Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease

Non-Tuberculous Mycobacterial Pneumonia Clinical Trial

— nutriNTM  

Official title:

Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease: an Exploratory Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05376280
• Other study ID #: nutriNTM
• Status: Recruiting
• Start date: April 20, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: University of Milano Bicocca
• Contact: Paola Faverio, MD
• Phone: +390392334579
• Email: paola.faverio[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The aim of the study is to evaluate the nutritional status in patients with non-tuberculous mycobacterial pulmonary disease (NTM-PD) and to provide an initial assessment of the potential impact of the introduction of targeted antibiotic therapy on the nutritional status itself. Specifically, the primary objective is the assessment of the proportion of underweight subjects, i.e. with Body Mass Index (BMI) <18.5 kg/m2, to confirm that it is significantly higher than that of the general Italian population. Study Design: Multicenter Cohort Pilot Observational Study Participation in the study consists of two pneumological visits, as per normal clinical practice, (at the beginning of the study, T1, after 6 months, T3, and at the end of the antimicobacterial antibiotic therapy, T5) in which the collection of past medical history, measurement of oxygen saturation, pulmonary functional tests and 6-minute walking tests will be performed. In addition, nutritional assessments (T2, T4, T6) will be carried out at the same time as the pulmonary visits. Nutritional assessments will include anthropometric measurements, questionnaires on nutritional status and physical activity, performing blood chemistry tests, bioimpedance, dynamometry and gait speed 4 meters, to evaluate body composition and physical performance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Mycobacterium Infections
• Non-Tuberculous Mycobacterial Pneumonia
• Pneumonia

Locations

Country	Name	City	State
Italy	IRCCS San Gerardo dei Tintori	Monza	MB

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI (body mass index)	kg/m2	baseline (NTM-PD diagnosis)
Secondary	FFMI (fat free mass index)	kg/m2	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Secondary	SMI (skeletal muscle mass index)	kg/m2	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Secondary	BFMI (body fat mass index)	kg/m2	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Secondary	Hand grip	kg/m2	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Secondary	Abdominal circumference	cm	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Secondary	Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST)	questionnaire score: score 0 = low risk of malnutrition; score 1 = medium risk of malnutrition; score equal or higher than 2 = high risk of malnutrition	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Secondary	Mini Nutritional Assessment (MNA)	questionnaire score (maximum score 30): total score > 23.5 = normal nutritional status; total score < 23.5 = inadequate nutritional status	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Secondary	plasma vitamin D	vitamin D level in plasma	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up