Probiotics in COPD: Effects on Symptoms, Lung Function, and Inflammation

NCT07339280 | Enrolling By Invitation

• 2 other identifiers: UHS-COPD-PROBIO-20252181-147/01-06/LJ.Z.-25-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this randomized, placebo controlled, double-blind clinical trial is to find out whether a probiotic supplement can help adults with chronic obstructive pulmonary disease (COPD) breathe better and better control their symptoms. The study will try to answer does taking a probiotic supplement, compare with a placebo, reduce shortness of breath, does it improve daily COPD symptoms or change stool patterns by using validated questionnaires; does it affect lung function or inflammation. The results of this study may contribute to a better understanding of the disease, the application of new therapeutic options, and provide a foundation for future research.

Conditions

COPD; Probiotic; COPD (Chronic Obstructive Pulmonary Disease); Probiotic Supplement

Keywords

COPD; Chronic Obstructive Pulmonary disease; mMRC; dyspnea; CAT; Interleukin-6; Probiotics; probiotic supplement; dietary supplement

Outcome Measures

Primary Outcomes (1)

• mMRC scale of dyspnea

  The primary objective of this study is to assess the degree of change in dyspnea, measured using the validated mMRC (Modified Medical Research Council) questionnaire in patients with COPD eight weeks after administration of the probiotic dietary supplement.

  8 weeks

Secondary Outcomes (18)

• CAT questionnaire

  8, 16 weeks

• Bristol stool scale

  8, 16 weeks

• mMRC

  4,12,16 weeks

• IL-6

  8 weeks

• Complete blood count

  8 and 16 weeks

Study Arms (2)

Probiotic arm

ACTIVE COMPARATOR

Participants will receive two capsules once daily of a probiotic dietary supplement for 16 weeks. The product will be coded to ensure blinding.

Dietary Supplement: Probiotic Capsule

Placebo arm

PLACEBO COMPARATOR

Participants will receive two capsules once daily of a placebo preparation for 16 weeks. The product will be coded to ensure blinding.

Dietary Supplement: placebo capsule

Interventions

placebo capsule DIETARY_SUPPLEMENT

Participants will receive two capsules per day for 16 weeks, a placebo preparation that is identical in composition and form to the probiotic but does not contain an active substance. The product will be coded for blinding purposes.

Also known as: placebo, placebo control

Placebo arm

Probiotic Capsule DIETARY_SUPPLEMENT

The participants will take two probiotic capsules per day for 16 weeks, containing S. boulardii, Lactobacillus plantarum LP 6596, and Lactobacillus plantarum HEAL9. The product will be coded for blinding purposes.

Also known as: Lactobacillus plantarum, Lac.plantarum HEAL9, Lac.plantarum LP 6596, Saccharomyces boulardii, dietary supplement, probiotic supplement

Probiotic arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a previously established diagnosis of COPD, regardless of the degree of airflow obstruction on pulmonary function testing.
• Age over 18 years, regardless of sex.
• Stable disease without exacerbations during the past two months (8 weeks).
• Stable disease without changes to maintenance therapy during the past two months (8 weeks).
• Patients with an mMRC score of 1 or higher.
• Signed informed consent.

You may not qualify if:

• patients diagnosed with serious comorbidities such as severe cardiovascular diseases (severe heart failure, acute coronary syndrome, or percutaneous coronary intervention within 6 months, uncontrolled tachy/bradyarrhythmias), patients with severe renal failure and a placed central venous catheter, patients with severe liver damage (Child-Pugh class C), patients with infectious hepatitis or HIV, active bloody diarrhea;
• patients undergoing active oncological and hematological treatment;
• patients who have had a stroke within the past 3 months;
• transplanted patients, including allograft recipients;
• patients on long-term systemic corticosteroid and immunosuppressive therapy (oral or intravenous form) as well as antifungal therapy,
• patients who have had a COPD exacerbation within the past two months and are not in a stable condition,
• patients diagnosed with asthma,
• patients with a history of lung surgery or serious respiratory diseases other than COPD (active tuberculosis, sarcoidosis, pulmonary fibrosis, severe bronchiectasis, pulmonary aspergillosis, etc.),
• patients who have recently participated in other clinical trials or have received experimental therapy,
• patients with a history of severe allergic reactions or hypersensitivity to the components of the probiotic preparation,
• patients with active alcoholism or drug addiction,
• patients with severe psychiatric diagnoses or those with significant physical or cognitive limitations that would interfere with following the study protocol,
• patients who have recently undergone surgery,
• pregnant or breastfeeding women,
• patients who have taken any probiotic preparations within one month before the start of the study,

Sponsors & Collaborators

• University Hospital of Split: lead
• Abela Pharmaceuticals, Inc.: collaborator

Study Sites (5)

General Hospital Karlovac

Karlovac, Croatia

Location

University Hospital Split

Split, 2100, Croatia

Location

General Hospital Sibenik

Šibenik, 2200, Croatia

Location

General Hospital Vinkovci

Vinkovci, Croatia

Location

University Hospital Centre Sestre milosrdnice

Zagreb, Croatia

Location

Related Publications (18)

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• Karim A, Muhammad T, Shahid Iqbal M, Qaisar R. A multistrain probiotic improves handgrip strength and functional capacity in patients with COPD: A randomized controlled trial. Arch Gerontol Geriatr. 2022 Sep-Oct;102:104721. doi: 10.1016/j.archger.2022.104721. Epub 2022 May 10.

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• Su Z, Ma C, Ru X, Zhang S, Wu C, Huang Y, Cen H, Yin Z, Zhang J. Effects of probiotic treatment on patients and animals with chronic obstructive pulmonary disease: a systematic review and meta-analysis of randomized control trials. Front Cell Infect Microbiol. 2024 Sep 11;14:1411222. doi: 10.3389/fcimb.2024.1411222. eCollection 2024.

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  BACKGROUND

• Agusti A, Celli BR, Criner GJ, Halpin D, Anzueto A, Barnes P, Bourbeau J, Han MK, Martinez FJ, Montes de Oca M, Mortimer K, Papi A, Pavord I, Roche N, Salvi S, Sin DD, Singh D, Stockley R, Lopez Varela MV, Wedzicha JA, Vogelmeier CF. Global Initiative for Chronic Obstructive Lung Disease 2023 Report: GOLD Executive Summary. Am J Respir Crit Care Med. 2023 Apr 1;207(7):819-837. doi: 10.1164/rccm.202301-0106PP. No abstract available.

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• MDCalc [Internet]. [cited 2025 Oct 7]. Mmrc (Modified medical research council) dyspnea scale. Available from: https://www.mdcalc.com/calc/4006/mmrc-modified-medical-research-council-dyspnea-scale

  BACKGROUND

• Huang H, Huang X, Zeng K, Deng F, Lin C, Huang W. Interleukin-6 is a Strong Predictor of the Frequency of COPD Exacerbation Within 1 Year. Int J Chron Obstruct Pulmon Dis. 2021 Oct 28;16:2945-2951. doi: 10.2147/COPD.S332505. eCollection 2021.

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• Global Initiative for Chronic Obstructive Lung Disease - GOLD [Internet]. [cited 2025 Oct 7]. Global initiative for chronic obstructive lung disease. Available from: https://goldcopd.org/

  BACKGROUND

• Research randomizer [Internet]. [cited 2025 Oct 7]. Available from: https://www.randomizer.org/.

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Probiotics; Dietary Supplements

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blinded

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 14, 2026
• Study Start: March 8, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CR (5)