NCT06717659

Probiotics in Pulmonaty Rehabilitation for COPD

Probiotics in the Management of Pulmonary Rehabilitation for COPD: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fu Jen Catholic University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
OTHER	probiotic supplementation intervention	probiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy
OTHER	standard pulmonnary rehabilitation	undergo routine pulmonary rehabilitation without probiotics intervention

Timeline

• Start date: 2024-12-05
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-12-05
• Last updated: 2026-02-27

Locations

1 site across 1 country: Taiwan