Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease

NCT05376280 | Unknown

• 1 other identifier: nutriNTM
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Tuberculous Mycobacterial Pneumonia

Keywords

nutrition; nutritional status; sarcopenia; malnutrition; body mass index; bioimpedance analysis

Outcome Measures

Primary Outcomes (1)

• BMI (body mass index)

  kg/m2

  baseline (NTM-PD diagnosis)

Secondary Outcomes (8)

• FFMI (fat free mass index)

  baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up

• SMI (skeletal muscle mass index)

  baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up

• BFMI (body fat mass index)

  baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up

• Hand grip

  baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up

• Abdominal circumference

  baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with a recent diagnosis of NTM-PD

You may qualify if:

• age greater than or equal to 18 years;
• diagnosis of NTM-PD according to the BTS 2017 guidelines

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Malnutrition

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Paola Faverio, MD

CONTACT

+390392334579; paola.faverio@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: April 20, 2022
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

IT (1)