Clinical trial NCT06717659: Probiotics in Pulmonaty Rehabilitation for COPD
Official title: Probiotics in the Management of Pulmonary Rehabilitation for COPD: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Probiotic Intervention
Body Composition Measurement
Keywords: body composition
inflammation markers
nutritional supplementation
probiotics
chronic obstructive pulmonary disease
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: interleukin-6
timeFrame: six weeks
Secondary outcomes:
measure: indirect calorimetry
timeFrame: six weeks
measure: body composition analysis
timeFrame: six weeks
measure: heart rate
timeFrame: six weeks
measure: saturation
timeFrame: six weeks
measure: systolic and diastolic pressure
timeFrame: six weeks
measure: respiratory rate
timeFrame: six weeks
measure: six minute walk test
timeFrame: six weeks
measure: time up and go
timeFrame: six weeks
measure: FEV1
timeFrame: six weeks
measure: FVC
timeFrame: six weeks
measure: FEV1/FVC
timeFrame: six weeks
measure: CRP
timeFrame: six weeks
measure: TNF-α
timeFrame: six weeks
measure: TMAO
timeFrame: six weeks
measure: The MDA of oxidative stress
timeFrame: six weeks
measure: modified medical research council
timeFrame: six weeks
measure: COPD assessment test
timeFrame: six weeks
measure: Borg dyspnea scale
timeFrame: six weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Fu Jen Catholic University
name: Ke-Yun Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References: