Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352, Taiwan
Location status: Recruiting
NCT Number: NCT06717659
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New Taipei City, 24352, Taiwan
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
probiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy
undergo routine pulmonary rehabilitation without probiotics intervention
Time frame: six weeks
inflammation evaluation
Time frame: six weeks
nutrition status
Time frame: six weeks
nutrition status
Time frame: six weeks
physiological parameters
Time frame: six weeks
physiological parameters
Time frame: six weeks
physiological parameters
Time frame: six weeks
physiological parameters
Time frame: six weeks
functional performance
Time frame: six weeks
functional performance
Time frame: six weeks
functional performance
Time frame: six weeks
functional performance
Time frame: six weeks
functional performance
Time frame: six weeks
biochemical blood tests
Time frame: six weeks
biochemical blood tests
Time frame: six weeks
biochemical blood tests
Time frame: six weeks
biochemical blood tests
Time frame: six weeks
self-perception questionnaire, maximun 4 and minimum 0, lower means a better outcome
Time frame: six weeks
self-perception questionnaire, maximun 40 and minimum 0, lower means a better outcome
Time frame: six weeks
self-perception questionnaire, maximun 10 and minimum 0, lower means a better outcome
Contact information is provided by the study sponsor or research team.
Fu Jen Catholic University
Other
Probiotics in the Management of Pulmonary Rehabilitation for COPD: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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