Probiotics in Pulmonaty Rehabilitation for COPD

Not Applicable

Recruiting

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

• Registration Number: NCT06717659
• Lead Sponsor: Fu Jen Catholic University

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.

Detailed Description

Background： Patients with chronic obstructive pulmonary disease (COPD) often suffer from malnutrition and weight loss, which negatively impact mortality rates. Research indicates that insufficient intake of fiber, vitamins, and folic acid is associated with airflow limitation in COPD. Malnutrition affects lung function and muscle strength, leading to difficulty in breathing and reduced exercise tolerance. Nutritional support interventions, such as probiotics, are valuable in improving the nutritional status, lung function, and pulmonary rehabilitation in COPD patients.

Study Design： This is a one-year, single-center, prospective randomized controlled trial.

Methods： This study is a randomized controlled trial targeting COPD patients undergoing pulmonary rehabilitation. The plan is to recruit 60 participants, randomly assigned to either the probiotic intervention group or the conventional pulmonary rehabilitation group. The study includes physiological parameters, functional tests, questionnaires, and blood biochemical analyses. Data will be analyzed using SPSS, with statistical significance set at p \< 0.05.

Effect： The trial expects that COPD patients receiving probiotic supplementation will achieve significant muscle gain and fat loss, reduce inflammation, and exhibit changes in body composition and functional performance.

Key words： Chronic obstructive pulmonary disease; probiotics; nutritional supplementation; inflammation markers; body composition

Study Timeline

• Study First Submitted: 2024-11-24
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Study Start: 2024-12-05
• Study First Posted: 2024-12-05
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
interleukin-6	six weeks	inflammation evaluation

Secondary Outcome Measures

Name	Time	Method
FEV1/FVC	six weeks	functional performance
CRP	six weeks	biochemical blood tests
TNF-α	six weeks	biochemical blood tests
TMAO	six weeks	biochemical blood tests
The MDA of oxidative stress	six weeks	biochemical blood tests
modified medical research council	six weeks	self-perception questionnaire, maximun 4 and minimum 0, lower means a better outcome
indirect calorimetry	six weeks	nutrition status
body composition analysis	six weeks	nutrition status
heart rate	six weeks	physiological parameters
saturation	six weeks	physiological parameters
systolic and diastolic pressure	six weeks	physiological parameters
respiratory rate	six weeks	physiological parameters
six minute walk test	six weeks	functional performance
time up and go	six weeks	functional performance
FEV1	six weeks	functional performance
FVC	six weeks	functional performance
COPD assessment test	six weeks	self-perception questionnaire, maximun 40 and minimum 0, lower means a better outcome
Borg dyspnea scale	six weeks	self-perception questionnaire, maximun 10 and minimum 0, lower means a better outcome

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University; 🇨🇳 New Taipei City, Taiwan