nutriNTM: NUTRITIONAL ASSESSMENT IN NON-TUBERCULOUS MYCOBACTERIA PULMONARY DISEASE

Sponsor

University of Milano Bicocca (Other)

Overall Status

Recruiting

CT.gov ID

NCT05376280

Collaborator

(none)

120

Enrollment

Location

26.3

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Tuberculous Mycobacterial Pneumonia

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

NUTRITIONAL ASSESSMENT IN NON-TUBERCULOUS MYCOBACTERIA PULMONARY DISEASE: AN EXPLORATORY STUDY

Actual Study Start Date :

Apr 20, 2022

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Outcome Measures

Primary Outcome Measures

BMI (body mass index) [baseline (NTM-PD diagnosis)]
kg/m2

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.