Probiotics in Pulmonaty Rehabilitation for COPD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Body Composition Measurement; COPD (Chronic Obstructive Pulmonary Disease); Probiotic Intervention
• Intervention / Treatment: Other: probiotic supplementation intervention; Other: standard pulmonnary rehabilitation

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ke-Yun Chao, PhD; Phone Number: +886-905-301-879; Email: C00152@mail.fjuh.fju.edu.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 24352
    • Recruiting
    • Fu Jen Catholic University Hospital, Fu Jen Catholic University
    • Principal Investigator: Ke-Yun Chao, PhD
    • Contact: Ke-Yun Chao, PhD; Phone Number: +886-905-301-879; Email: C00152@mail.fjuh.fju.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: probiotic group; receive probiotics alongside standard pulmonary rehabilitation therapy	Other: probiotic supplementation intervention; probiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy
Active Comparator: pulmonary rehabilitation group; undergo only the standard pulmonary rehabilitation program	Other: standard pulmonnary rehabilitation; undergo routine pulmonary rehabilitation without probiotics intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
interleukin-6	inflammation evaluation	six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
indirect calorimetry	nutrition status	six weeks
body composition analysis	nutrition status	six weeks
heart rate	physiological parameters	six weeks
saturation	physiological parameters	six weeks
systolic and diastolic pressure	physiological parameters	six weeks
respiratory rate	physiological parameters	six weeks
six minute walk test	functional performance	six weeks
time up and go	functional performance	six weeks
FEV1	functional performance	six weeks
FVC	functional performance	six weeks
FEV1/FVC	functional performance	six weeks
CRP	biochemical blood tests	six weeks
TNF-α	biochemical blood tests	six weeks
TMAO	biochemical blood tests	six weeks
The MDA of oxidative stress	biochemical blood tests	six weeks
modified medical research council	self-perception questionnaire, maximun 4 and minimum 0, lower means a better outcome	six weeks
COPD assessment test	self-perception questionnaire, maximun 40 and minimum 0, lower means a better outcome	six weeks
Borg dyspnea scale	self-perception questionnaire, maximun 10 and minimum 0, lower means a better outcome	six weeks

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University
• Investigators: Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: probiotics; body composition; chronic obstructive pulmonary disease; nutritional supplementation; inflammation markers
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: FJUH113385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No