Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659 | Recruiting

• 1 other identifier: FJUH113385
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate various aspects of patients with chronic respiratory diseases undergoing pulmonary rehabilitation supplemented with probiotics. The focus will be on clinical physiological responses, functional performance, respiratory status assessments, nutritional status evaluations, body composition analyses, and biochemical blood parameters, with a primary emphasis on the anti-inflammatory response.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Probiotic Intervention; Body Composition Measurement

Keywords

body composition; inflammation markers; nutritional supplementation; probiotics; chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• interleukin-6

  inflammation evaluation

  six weeks

Secondary Outcomes (18)

• indirect calorimetry

  six weeks

• body composition analysis

  six weeks

• heart rate

  six weeks

• saturation

  six weeks

• systolic and diastolic pressure

  six weeks

Study Arms (2)

probiotic group

EXPERIMENTAL

receive probiotics alongside standard pulmonary rehabilitation therapy

Other: probiotic supplementation intervention

pulmonary rehabilitation group

ACTIVE COMPARATOR

undergo only the standard pulmonary rehabilitation program

Other: standard pulmonnary rehabilitation

Interventions

probiotic supplementation intervention OTHER

probiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy

probiotic group

standard pulmonnary rehabilitation OTHER

undergo routine pulmonary rehabilitation without probiotics intervention

pulmonary rehabilitation group

Eligibility Criteria

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

You may qualify if:

• Willing to sign a written informed consent form.
• Diagnosed with pre-COPD or COPD stage I-IV according to the 2023 GOLD guidelines.
• Undergoing pulmonary rehabilitation therapy for more than three months.

You may not qualify if:

• Under 18 years old.
• Diagnosed with neuromuscular diseases.
• Experienced respiratory disease exacerbation requiring emergency care or hospitalization in the past three months.
• Unable to cooperate with cardiopulmonary exercise testing.
• Has other diseases or behavioral restrictions preventing participation in exercise training for over one year.
• Assessed by a physician to have severe malnutrition or a significantly low BMI.

Sponsors & Collaborators

• Fu Jen Catholic University: lead

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ke-Yun Chao, PhD

  Fu Jen Catholic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Yun Chao, PhD

CONTACT

+886-905-301-879; C00152@mail.fjuh.fju.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 5, 2024
• Study Start: December 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)