Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease (nutriNTM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Paola Faverio, MD; Phone Number: +390392334579; Email: paola.faverio@gmail.com

Study Locations

• Italy
  • MB
    • Monza, MB, Italy, 20900
      • Recruiting
      • IRCCS San Gerardo dei Tintori
      • Contact: Paola Faverio, MD; Phone Number: 0392339040; Email: paola.faverio@unimib.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with a recent diagnosis of NTM-PD

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI (body mass index)	kg/m2	baseline (NTM-PD diagnosis)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FFMI (fat free mass index)	kg/m2	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
SMI (skeletal muscle mass index)	kg/m2	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
BFMI (body fat mass index)	kg/m2	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Hand grip	kg/m2	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Abdominal circumference	cm	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
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
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
plasma vitamin D	vitamin D level in plasma	baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up

Collaborators and Investigators

• Sponsor: University of Milano Bicocca

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: body mass index; nutritional status; nutrition; sarcopenia; malnutrition; bioimpedance analysis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Lung Diseases; Mycobacterium Infections; Pneumonia
• Other Study ID Numbers: nutriNTM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No