NCT05376280

Unknown

Nutritional Assessment in Non-tuberculous Mycobacteria Pulmo...

University of Milano Bicocca Source

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Other study identifiers

Sponsor study identifier

nutriNTM

Study Type

observational

Estimated enrollment

120

Locations

1 country

Sites

1

Timeline

Study Start

April 20, 2022

Actual (reported)

Primary Completion

April 30, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 30, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 120 participants
Study completion date: June 30, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 20, 2022
Actual (reported)
First Submitted
May 11, 2022
Actual (reported)
First Posted
May 17, 2022
Actual (reported)
Primary Completion
April 30, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: January 11, 2024
Status Verified: January 2024
Last Update Submitted: January 9, 2024

Conditions

Non-Tuberculous Mycobacterial Pneumonia

Keywords

nutritionnutritional statussarcopeniamalnutritionbody mass indexbioimpedance 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
+3 more secondary outcomes

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adults with a recent diagnosis of NTM-PD

You may qualify if:

age greater than or equal to 18 years;

Sponsors & Collaborators

University of Milano Bicocca
Otherlead

Study Sites (1)

IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

RECRUITING

Paola Faverio, MDCONTACT0392339040 paola.faverio@unimib.it

MeSH Terms

Conditions

SarcopeniaMalnutrition

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsNutrition DisordersNutritional 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

Actual (reported)

Primary Completion

April 30, 2024

Estimated (date passed)

NCT06522347

Mycobacteria Registry Study: Prospective Observational Study in Austria

Recruiting

NCT06144996

Development of a Canadian Bronchiectasis and NTM Database

Recruiting

NCT03794284

Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium

Completed

NCT03934034

A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.

Not Yet Recruiting

NCT04600232

TB-LAM in the Diagnosis of TB

Not ApplicableUnknown

NCT04079400

Microbiome in Pulmonary Tuberculosis, Non-tuberculous Mycobacterial Pulmonary Diseases, Lung Cancer and Hemoptysis

Completed

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.

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 30, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

January 11, 2024

Record last verified: 2024-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05376280
Data provider: ClinicalTrials.gov
Source updated: 2024-01-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:46 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations