Association of Nutrition and T Cell Immune Activity With Disease Progression in Nontuberculous Mycobacterial Pulmonary Disease

NCT07363798 | Not Yet Recruiting

• 1 other identifier: BRMH 20-2025-65
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Nontuberculous mycobacterial pulmonary disease (NTM-PD) is a chronic lung infection caused by environmental mycobacteria. The clinical course of NTM-PD varies widely among patients. Some individuals remain stable for long periods without treatment, while others experience worsening lung disease that requires antibiotic therapy or may lead to death. Currently available clinical tools are limited in their ability to predict which patients will experience disease progression. This observational study aims to better understand how the body's immune response and nutritional status are related to disease progression in adults with confirmed or suspected NTM-PD. In particular, the study focuses on T cells, a type of immune cell that plays an important role in controlling mycobacterial infections. Prior research suggests that impaired T-cell function may contribute to disease progression in NTM-PD, but most studies have relied on blood samples rather than immune cells from the lung, where the infection occurs. In this study, immune cells obtained from bronchoalveolar lavage fluid during clinically indicated bronchoscopy will be analyzed to assess inhibitory and exhausted T-cell profiles in the lung. In addition, systemic T-cell function will be evaluated using the mitogen response from the QuantiFERON-TB Gold Plus blood test. Nutritional status and body composition will also be assessed, as poor nutrition is known to affect immune function and disease outcomes. Participants will be followed over time as part of routine clinical care. The primary outcome of the study is the time from enrollment to the initiation of antibiotic treatment due to clinical disease progression. Secondary outcomes include identifying immune predictors of treatment initiation, examining the relationship between nutritional status and immune activity, evaluating changes in body composition and immune markers with disease progression, and determining whether immune and nutritional measures improve prediction of mortality beyond established clinical risk scores. By integrating lung immune profiling, blood-based immune testing, nutritional assessment, and clinical data, this study seeks to improve risk stratification in NTM-PD. The results may help identify patients at higher risk for disease progression and poor outcomes, support more personalized monitoring strategies, and inform future studies targeting immune and nutritional pathways in NTM-PD.

Conditions

Nontuberculous Mycobacterial Pulmonary Disease; Nontuberculous Mycobacterial Lung Disease

Keywords

Nontuberculous mycobacterial pulmonary disease; Bronchoalveolar lavage; T cell exhaustion; Disease progression; Nutritional status

Outcome Measures

Primary Outcomes (1)

• Time to initiation of treatment due to disease progression in nontuberculous mycobacterial pulmonary disease

  Time to treatment initiation is defined as the duration from study enrollment to the start of antimicrobial therapy for nontuberculous mycobacterial pulmonary disease due to clinical disease progression. Treatment initiation is determined by the treating physician based on standard clinical practice and guideline-based criteria, including worsening respiratory symptoms, microbiologic findings, and/or radiographic deterioration indicating progression requiring treatment. This primary outcome is used to evaluate the association between time to treatment initiation and immune predictors, including bronchoalveolar lavage-derived inhibitory and exhausted T-cell profiles and systemic T-cell functional capacity, assessed by the QuantiFERON mitogen response, along with other clinical factors.

  From enrollment to initiation of nontuberculous mycobacterial treatment, up to 24 months

Secondary Outcomes (14)

• Proportion of regulatory T cells in bronchoalveolar lavage fluid (BAL) at baseline

  Baseline

• Proportion of exhausted T cells in BAL fluid at baseline

  Baseline

• QuantiFERON-TB Gold Plus mitogen response at baseline (IU/mL)

  Baseline

• Body Mass Index (BMI) at baseline (kg/m²)

  Baseline

• Mini Nutritional Assessment (MNA) score at baseline

  Baseline

Study Arms (1)

NTM-PD cohort

This cohort includes adults (≥18 years) with confirmed or suspected nontuberculous mycobacterial pulmonary disease (NTM-PD) in whom active pulmonary tuberculosis has been excluded and who are undergoing bronchoscopy as part of routine clinical care. Participants receive standard-of-care evaluation and management according to established NTM clinical guidelines. There are no experimental interventions assigned in this study. Residual bronchoalveolar lavage fluid remaining after clinically indicated testing is used for immunologic analyses, including flow cytometric assessment of inhibitory and exhausted T-cell subsets. Clinical data, nutritional status, imaging findings, and laboratory results are collected prospectively, and participants are followed longitudinally to assess time to initiation of antimicrobial treatment due to clinical disease progression and other clinically relevant outcomes.

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

Participants will be recruited from adults with confirmed or suspected nontuberculous mycobacterial pulmonary disease who are scheduled to undergo bronchoscopy as part of routine clinical evaluation or disease monitoring according to established NTM management guidelines. The study population consists of patients receiving standard-of-care clinical assessment and follow-up, without any additional procedures performed solely for research purposes.

You may qualify if:

• Adults aged 18 years or older
• Confirmed or suspected nontuberculous mycobacterial pulmonary disease
• Active pulmonary tuberculosis excluded by standard microbiologic testing
• Undergoing bronchoscopy as part of routine clinical evaluation or disease monitoring
• Able and willing to provide written informed consent

You may not qualify if:

• Active pulmonary tuberculosis confirmed by microbiologic testing
• Positive latent tuberculosis infection test
• Current active malignancy requiring treatment
• History of solid organ transplantation or hematopoietic stem cell transplantation
• Use of systemic immunosuppressive medications
• Diagnosis of autoimmune disease
• Use of biologic agents or planned initiation of biologic therapy
• Acute lower respiratory tract infection requiring treatment within 4 weeks prior to bronchoscopy
• Pregnancy

Sponsors & Collaborators

• Seoul National University Hospital: lead
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, Dongjak-gu, 07061, South Korea

Location

Related Publications (17)

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MeSH Terms

Conditions

Disease Progression

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Deog Kyeom Kim, MD, PhD

CONTACT

+82-2-870-2228; kimdkmd@gmail.com

Heemoon Park, MD

CONTACT

+82-2-870-3439; coramdeo33@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Department of Pulmonary and Critical Care Medicine, SMG-SNU Boramae Medical Center

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 23, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)