Probiotics in Pulmonaty Rehabilitation for COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: probiotic supplementation intervention, standard pulmonnary rehabilitation.
- Who it may be relevant to
- Registry conditions: COPD (Chronic Obstructive Pulmonary Disease), Probiotic Intervention, Body Composition Measurement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Probiotics in the Management of Pulmonary Rehabilitation for COPD: A Randomized Controlled Trial
Overview
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
Interventions
- 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
Primary outcome measures
- interleukin-6 [Time frame: six weeks]
Secondary outcome measures (12)
- indirect calorimetry [Time frame: six weeks]
- body composition analysis [Time frame: six weeks]
- heart rate [Time frame: six weeks]
- saturation [Time frame: six weeks]
- systolic and diastolic pressure [Time frame: six weeks]
- respiratory rate [Time frame: six weeks]
- six minute walk test [Time frame: six weeks]
- time up and go [Time frame: six weeks]
- FEV1 [Time frame: six weeks]
- FVC [Time frame: six weeks]
- FEV1/FVC [Time frame: six weeks]
- CRP [Time frame: six weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Taiwan · 1 center
- Fu Jen Catholic University Hospital, Fu Jen Catholic University — New Taipei City
Identifiers
NCT: NCT06717659 · FJUH113385