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NCT Number: NCT06717659

Probiotics in Pulmonaty Rehabilitation for COPD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

Location status: Recruiting

Location contact

Ke-Yun Chao, PhD

CONTACT

[email protected]

+886-905-301-879

Ke-Yun Chao, PhD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

probiotic supplementation intervention

Other

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

standard pulmonnary rehabilitation

Other

undergo routine pulmonary rehabilitation without probiotics intervention

Primary outcomes

  1. interleukin-6

    Time frame: six weeks

    inflammation evaluation

Secondary outcomes

  1. indirect calorimetry

    Time frame: six weeks

    nutrition status

  2. body composition analysis

    Time frame: six weeks

    nutrition status

  3. heart rate

    Time frame: six weeks

    physiological parameters

  4. saturation

    Time frame: six weeks

    physiological parameters

  5. systolic and diastolic pressure

    Time frame: six weeks

    physiological parameters

  6. respiratory rate

    Time frame: six weeks

    physiological parameters

  7. six minute walk test

    Time frame: six weeks

    functional performance

  8. time up and go

    Time frame: six weeks

    functional performance

  9. FEV1

    Time frame: six weeks

    functional performance

  10. FVC

    Time frame: six weeks

    functional performance

  11. FEV1/FVC

    Time frame: six weeks

    functional performance

  12. CRP

    Time frame: six weeks

    biochemical blood tests

  13. TNF-α

    Time frame: six weeks

    biochemical blood tests

  14. TMAO

    Time frame: six weeks

    biochemical blood tests

  15. The MDA of oxidative stress

    Time frame: six weeks

    biochemical blood tests

  16. modified medical research council

    Time frame: six weeks

    self-perception questionnaire, maximun 4 and minimum 0, lower means a better outcome

  17. COPD assessment test

    Time frame: six weeks

    self-perception questionnaire, maximun 40 and minimum 0, lower means a better outcome

  18. Borg dyspnea scale

    Time frame: six weeks

    self-perception questionnaire, maximun 10 and minimum 0, lower means a better outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Ke-Yun Chao, PhD

CONTACT

[email protected]

+886-905-301-879

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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