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Probiotics in Pulmonaty Rehabilitation for COPD

NCT ID: NCT06717659

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-05

Study Completion Date

2025-07-31

Brief Summary

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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

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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

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

Keywords

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body composition inflammation markers nutritional supplementation probiotics chronic obstructive pulmonary disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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probiotic group

receive probiotics alongside standard pulmonary rehabilitation therapy

Group Type EXPERIMENTAL

probiotic supplementation intervention

Intervention Type OTHER

probiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy

pulmonary rehabilitation group

undergo only the standard pulmonary rehabilitation program

Group Type ACTIVE_COMPARATOR

standard pulmonnary rehabilitation

Intervention Type OTHER

undergo routine pulmonary rehabilitation without probiotics intervention

Interventions

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probiotic supplementation intervention

probiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy

Intervention Type OTHER

standard pulmonnary rehabilitation

undergo routine pulmonary rehabilitation without probiotics intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Ke-Yun, Chao

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ke-Yun Chao, PhD

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University

Locations

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Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ke-Yun Chao, PhD

Role: CONTACT

Phone: +886-905-301-879

Email: [email protected]

Facility Contacts

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Ke-Yun Chao, PhD

Role: primary

Ke-Yun Chao, PhD

Role: backup

Other Identifiers

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FJUH113385

Identifier Type: -

Identifier Source: org_study_id