Non-Tuberculous Mycobacterial PneumonianutriNTMNCT05376280
Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease
An observational study of Non-Tuberculous Mycobacterial Pneumonia, run by University of Milano Bicocca at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Tuberculous Mycobacterial Pneumonia
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a recent diagnosis of NTM-PD
Who may be able to join
- age greater than or equal to 18 years;
- diagnosis of NTM-PD according to the BTS 2017 guidelines
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Gerardo dei Tintori
Monza, MB, 20900
Paola Faverio, MD, 0392339040, paola.faverio@unimib.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia
- Keywords
- nutrition, nutritional status, sarcopenia, malnutrition, body mass index, bioimpedance analysis
- Medical subject headings
- Sarcopenia, Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (body mass index)
kg/m2
Measured: baseline (NTM-PD diagnosis)
Secondary outcomes (8)
FFMI (fat free mass index)
kg/m2
Measured: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
SMI (skeletal muscle mass index)
kg/m2
Measured: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
BFMI (body fat mass index)
kg/m2
Measured: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Hand grip
kg/m2
Measured: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Abdominal circumference
cm
Measured: 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
Measured: 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
Measured: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
plasma vitamin D
vitamin D level in plasma
Measured: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start20 Apr 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Tuberculous Mycobacterial PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola Faverio, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376280
- Sponsor's protocol ID
- nutriNTM
- Acronym
- nutriNTM
- Status last verified
- Jan 2024
- First submitted
- 11 May 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease: an Exploratory Study
- ClinicalTrials.gov ID
- NCT05376280
- Acronym / sponsor ID
- nutriNTM / nutriNTM
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia
- Keywords
- nutrition, nutritional status, sarcopenia, malnutrition, body mass index, bioimpedance analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a recent diagnosis of NTM-PD
Key inclusion criteria (2 listed)
- age greater than or equal to 18 years;
- diagnosis of NTM-PD according to the BTS 2017 guidelines
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BMI (body mass index)
Time frame: baseline (NTM-PD diagnosis)
kg/m2
8 secondary outcomes
FFMI (fat free mass index)
Time frame: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
SMI (skeletal muscle mass index)
Time frame: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
BFMI (body fat mass index)
Time frame: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Hand grip
Time frame: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Abdominal circumference
Time frame: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Malnutrition Universal Screening Tool (MUST) Screening Tool (MUST)
Time frame: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Mini Nutritional Assessment (MNA)
Time frame: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
plasma vitamin D
Time frame: baseline (NTM-PD diagnosis), 6-month follow-up, 12-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Tuberculous Mycobacterial Pneumonia, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Faverio, MD (+390392334579, paola.faverio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (body mass index) (time frame: baseline (NTM-PD diagnosis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.