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

NCT ID: NCT07339280

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2030-12-31

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.

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a progressive respiratory condition characterized by persistent symptoms such as shortness of breath, chronic cough, sputum production, and periods of acute worsening. It is also associated with ongoing systemic inflammation, which contributes to symptom severity, impaired lung function, and increased risk of exacerbations. Emerging evidence suggests that the gut-lung axis may play a significant role in this inflammatory process. Probiotics, which help restore a healthy microbial balance and support gut barrier integrity, have been proposed as a potential strategy to modulate inflammation and respiratory symptoms. Several studies have suggested that probiotics may reduce respiratory symptoms, improve lung function and lower systemic inflammation in people with COPD.

This randomized study is designed to evaluate whether a probiotic supplement (Saccharomyces boulardii, Lactobacillus plantarum LP 6596, and Lactobacillus plantarum HEAL9) can improve shortness of breath, overall symptom burden, lung function, and selected inflammatory markers in adults with stable COPD compared with placebo. Participants will be recruited from multiple clinical centers and will continue their usual COPD therapy throughout the study period. A total of 60 adult participants with a confirmed diagnosis of COPD, stable disease and baseline dyspnea of mMRC (modified Medical Research Council) ≥ 1 will be randomized to receive either a probiotic supplement or placebo for 16 weeks. They will take either the probiotic supplement or placebo 2 capsules once daily for 16 weeks and will be examined at three clinic visits for symptom questionnaires- mMRC scale of dyspnea, CAT (COPD Assessment Test) and Bristol Stool Scale, blood sampling, and spirometry testing. Between clinic visits, participants will have regular telephone checks every 4 weeks to assess symptoms, adherence to the study product and possible side effects.

This trial aims to provide a more comprehensive understanding of how probiotic supplementation may influence dyspnea, quality of life, inflammatory activity, and respiratory function in COPD.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic arm

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

Group Type: ACTIVE_COMPARATOR

Probiotic Capsule

Intervention Type: 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.

Placebo arm

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

Group Type: PLACEBO_COMPARATOR

placebo capsule

Intervention Type: 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.

Interventions

Probiotic Capsule

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.

Intervention Type: DIETARY_SUPPLEMENT

placebo capsule

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Lactobacillus plantarum; Lac.plantarum HEAL9; Lac.plantarum LP 6596; Saccharomyces boulardii; dietary supplement; probiotic supplement; placebo; placebo control

Eligibility Criteria

Inclusion Criteria

1. Patients with a previously established diagnosis of COPD, regardless of the degree of airflow obstruction on pulmonary function testing.

2. Age over 18 years, regardless of sex.

3. Stable disease without exacerbations during the past two months (8 weeks).

4. Stable disease without changes to maintenance therapy during the past two months (8 weeks).

5. Patients with an mMRC score of 1 or higher.

6. Signed informed consent.

Exclusion Criteria

1. 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;

2. patients undergoing active oncological and hematological treatment;

3. patients who have had a stroke within the past 3 months;

4. transplanted patients, including allograft recipients;

5. patients on long-term systemic corticosteroid and immunosuppressive therapy (oral or intravenous form) as well as antifungal therapy,

6. patients who have had a COPD exacerbation within the past two months and are not in a stable condition,

7. patients diagnosed with asthma,

8. patients with a history of lung surgery or serious respiratory diseases other than COPD (active tuberculosis, sarcoidosis, pulmonary fibrosis, severe bronchiectasis, pulmonary aspergillosis, etc.),

9. patients who have recently participated in other clinical trials or have received experimental therapy,

10. patients with a history of severe allergic reactions or hypersensitivity to the components of the probiotic preparation,

11. patients with active alcoholism or drug addiction,

12. patients with severe psychiatric diagnoses or those with significant physical or cognitive limitations that would interfere with following the study protocol,

13. patients who have recently undergone surgery,

14. pregnant or breastfeeding women,

15. patients who have taken any probiotic preparations within one month before the start of the study,

16. patients whose COPD treatment is changed during the course of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abela Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

University Hospital of Split

OTHER

Sponsor Role: lead

Responsible Party

Andrea Anić Matić,MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Split

Split, , Croatia

General Hospital Sibenik

Šibenik, , Croatia

General Hospital Vinkovci

Vinkovci, , Croatia

Countries

Croatia

Central Contacts

Andrea Anic-Matic, MD

Role: CONTACT

andrea.a.matic@gmail.com

+385 917877763

Suzana Mladinov, Assoc. Prof., PhD, MD

Role: CONTACT

suzana.mladinov@gmail.com

+385 95 9021 477

Facility Contacts

Role: primary

andrea.a.matic@gmail.com

00385 91 787 7763

References

Koblizek V, Milenkovic B, Barczyk A, Tkacova R, Somfay A, Zykov K, Tudoric N, Kostov K, Zbozinkova Z, Svancara J, Sorli J, Krams A, Miravitlles M, Valipour A. Phenotypes of COPD patients with a smoking history in Central and Eastern Europe: the POPE Study. Eur Respir J. 2017 May 11;49(5):1601446. doi: 10.1183/13993003.01446-2016. Print 2017 May.

Reference Type: BACKGROUND

PMID: 28495687 (View on PubMed)

Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.

Reference Type: BACKGROUND

PMID: 10377201 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35567889 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39324058 (View on PubMed)

Patibandla S, Bhatt N, Lief S, Beauti SM, Ansari AZ. Gut Microbiota Modulation in the Management of Chronic Obstructive Pulmonary Disease: A Literature Review. Cureus. 2024 Aug 14;16(8):e66875. doi: 10.7759/cureus.66875. eCollection 2024 Aug.

Reference Type: BACKGROUND

PMID: 39280360 (View on PubMed)

Panahi Y, Ghanei M, Vahedi E, Mousavi SH, Imani S, Sahebkar A. Efficacy of probiotic supplementation on quality of life and pulmonary symptoms due to sulfur mustard exposure: a randomized double-blind placebo-controlled trial. Drug Chem Toxicol. 2017 Jan;40(1):24-29. doi: 10.3109/01480545.2016.1166250. Epub 2016 Apr 14.

Reference Type: BACKGROUND

PMID: 27079636 (View on PubMed)

Aghamohammadi M, Ghodrati S, Jalili N, Jafari R, Rafiee E, Kamali K, Ghasemi M, Alizargar J. Effects of the oral probiotic Familact on dyspnea management in COPD patients: A randomized controlled trial. Heart Lung. 2025 May-Jun;71:63-68. doi: 10.1016/j.hrtlng.2025.02.002. Epub 2025 Feb 27.

Reference Type: BACKGROUND

PMID: 40020522 (View on PubMed)

Ertan Yazar E, Niksarlioglu EY, Yigitbas B, Bayraktaroglu M. How to Utilize CAT and mMRC Scores to Assess Symptom Status of Patients with COPD in Clinical Practice? Medeni Med J. 2022 Jun 23;37(2):173-179. doi: 10.4274/MMJ.galenos.2022.06787.

Reference Type: BACKGROUND

PMID: 35735170 (View on PubMed)

Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.

Reference Type: BACKGROUND

PMID: 14999112 (View on PubMed)

Nishimura K, Izumi T, Tsukino M, Oga T. Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD. Chest. 2002 May;121(5):1434-40. doi: 10.1378/chest.121.5.1434.

Reference Type: BACKGROUND

PMID: 12006425 (View on PubMed)

Sethi DK, Rhodes J, Ferris R, Banka R, Clarke A, Mishra EK. Breathlessness Predicts Mortality in Adults: A Systematic Review and Meta-Analysis. Cureus. 2023 May 18;15(5):e39192. doi: 10.7759/cureus.39192. eCollection 2023 May.

Reference Type: BACKGROUND

PMID: 37332470 (View on PubMed)

Kantatong T, Deesomchok A, Panpanich R, Sungkarat S, Siviroj P. Predicting quality of life in chronic obstructive pulmonary disease patients living in the rural area of chiang mai province, thailand. TOPHJ [Internet]. 2020 July 30 [cited 2025 Nov 1];13(1):357-64. Available from: https://openpublichealthjournal.com/VOLUME/13/PAGE/357/

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 36856433 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 34737559 (View on PubMed)

Li CL, Liu SF. Exploring Molecular Mechanisms and Biomarkers in COPD: An Overview of Current Advancements and Perspectives. Int J Mol Sci. 2024 Jul 4;25(13):7347. doi: 10.3390/ijms25137347.

Reference Type: BACKGROUND

PMID: 39000454 (View on PubMed)

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/

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

2181-147/01-06/LJ.Z.-25-02

Identifier Type: REGISTRY

Identifier Source: secondary_id

UHS-COPD-PROBIO-2025

Identifier Type: -

Identifier Source: org_study_id