COPDNCT07339280
Probiotics in COPD: Effects on Symptoms, Lung Function, and Inflammation
A study testing Probiotic Capsule in people with COPD and COPD (Chronic Obstructive Pulmonary Disease), run by University Hospital of Split at 5 sites in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, COPD (Chronic Obstructive Pulmonary Disease), Probiotic
- What is being tested?
- Probiotic Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 5 sitesCroatia
- Study dates
- 8 Mar 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 16Show fewer
- 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,
- patients whose COPD treatment is changed during the course of the study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Croatia5 sites
General Hospital Karlovac
Karlovac
General Hospital Sibenik
Šibenik, 2200
University Hospital Split
Split, 2100
General Hospital Vinkovci
Vinkovci
University Hospital Centre Sestre milosrdnice
Zagreb
About this study
Official title: "The Effect of Probiotics on the Degree of Dyspnea, Lung Function, and Inflammatory Mediators in Patients With Chronic Obstructive Pulmonary Disease (COPD)."
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.
Read the 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.
- Being tested
- Probiotic Capsule, placebo capsule
- Keywords
- COPD, Chronic Obstructive Pulmonary disease, mMRC, dyspnea, CAT, Interleukin-6, Probiotics, probiotic supplement, dietary supplement
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic CapsuleDietary supplement
Also called Lactobacillus plantarum, Lac.plantarum HEAL9, Lac.plantarum LP 6596, Saccharomyces boulardii
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 capsuleDietary supplement
Also called placebo, placebo control
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (18)
CAT questionnaire
To evaluate the effect of probiotic therapy on symptom control and quality of life in COPD patients using the validated CAT (COPD Assessment Test) questionnaire after 4, 8, 12, and 16 weeks of probiotic administration.
Measured: 8, 16 weeks
Bristol stool scale
To assess the effect of probiotic therapy on stool appearance using the Bristol Stool Scale at baseline and after 8 and 16 weeks of probiotic administration.
Measured: 8, 16 weeks
mMRC
To evaluate changes in dyspnea severity on the mMRC scale after 4, 12, and 16 weeks of probiotic administration.
Measured: 4,12,16 weeks
IL-6
Changes in laboratory-measured IL-6 (interleukin-6) levels at baseline and after 8 weeks of probiotic administration.
Measured: 8 weeks
Complete blood count
To investigate the effect of probiotics on changes in concentration of total leukocyte count (×10⁹/L) with differential ((concentration of neutrophil count (×10⁹/L) , eosinophil count (×10⁹/L), monocyte (×10⁹/L) and lymphocyte count (×10⁹/L)) at baseline and after 8 and 16 weeks.
Measured: 8 and 16 weeks
Fibrinogen
To evaluate changes in serum concentration of fibrinogen (g/L) from baseline and after 8 and 16 weeks of probiotic administration.
Measured: 8 and 16 weeks
CRP
To evaluate changes in serum concentration of CRP (C-reactive protein) in mg/L from baseline and after 8 and 16 weeks of probiotic administration.
Measured: 8 and 16 weeks
Metabolic blood parameters-glucose
To assess changes in concentration of plasma glucose (mmol/L) measured at baseline and after 8 and 16 weeks of probiotic administration.
Measured: 8, 16 weeks
Metabolic blood parameters-urea
To assess changes in urea concentration (mmol/L) measured at baseline, 8 weeks, and 16 weeks of probiotic administration.
Measured: 8, 16 weeks
Metabolic blood parameters-creatinine
To assess changes in creatinine concentration (µmol/L) measured at baseline, 8 weeks, and 16 weeks.
Measured: 8, 16 weeks
Metabolic blood parameters-liver enzymes
To assess changes in activity of Aspartate Aminotransferase (AST) A (U/L), Alanine Aminotransferase (ALT) (U/L) and Gamma-Glutamyl Transferase (GGT) (U/L) at baseline and after 8 and 16 weeks of probiotic administration.
Measured: 8, 16 weeks
Metabolic blood parameters-electrolytes
To assess changes in concentration of sodium (mmol/L), potassium (mmol/L), and chloride (mmol/L) at baseline, after 8 and 16 weeks of probiotic administration.
Measured: 8, 16 weeks
Metabolic blood parameters-lipid profile
To assess changes in concentration of total cholesterol (mmol/L), High-Density Lipoprotein-HDL(mmol/L), Low-Density Lipoprotein-LDL(mmol/L), triglycerides (mmol/L) at baseline, 8 weeks, and 16 weeks of probiotic administration.
Measured: 8, 16 weeks
Lung function
To evaluate the effect of probiotics on spirometry-derived values: FEV₁% (forced expiratory volume in one second) (L), FVC% (forced vital capacity) (L), and the FEV₁/FVC ratio after bronchodilator testing at baseline and after 16 weeks of probiotic administration .
Measured: 16 weeks
Acute exacerbations
To investigate the effect of probiotic strains on the incidence of acute exacerbations after 16 weeks.
Measured: 16 weeks
Correlation IL-6 and CRP
To determine the correlation between IL-6 concentration and CRP after 8 weeks of probiotic administration.
Measured: 8 weeks
Other correlations
To determine the correlation between CRP concentration and spirometry findings (FEV₁ and the FEV₁/FVC ratio); correlation between fibrinogen levels and spirometry findings (FEV₁ and the FEV₁/FVC ratio); correlation between leukocyte count and spirometry findings (FEV₁ and the FEV₁/FVC ratio) after 16 weeks of probiotic administration.
Measured: 16 weeks
BMI
To evaluate the effect of probiotic strain administration on changes in body mass index (BMI) after 16 weeks of probiotic administration.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start8 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Collaborators
- Abela Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Andrea Anić Matić,MD, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339280
- Sponsor's protocol ID
- UHS-COPD-PROBIO-2025
- Other IDs
- 2181-147/01-06/LJ.Z.-25-02
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves sensitive health information, and data sharing is not covered by the informed consent form or approved by the ethics committee. Only aggregated, anonymized study results will be made publicly available.
Publications
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.
PubMed 28495687Bestall 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.
PubMed 10377201Karim 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.
PubMed 35567889Su 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.
PubMed 39324058Patibandla 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.
PubMed 39280360Panahi 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.
PubMed 27079636Aghamohammadi 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.
PubMed 40020522Ertan 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.
PubMed 35735170Celli 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.
PubMed 14999112Nishimura 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.
PubMed 12006425Sethi 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.
PubMed 37332470Kantatong 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/
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.
PubMed 36856433MDCalc [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
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.
PubMed 34737559
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Probiotics on the Degree of Dyspnea, Lung Function, and Inflammatory Mediators in Patients With Chronic Obstructive Pulmonary Disease (COPD)."
- ClinicalTrials.gov ID
- NCT07339280
- Acronym / sponsor ID
- UHS-COPD-PROBIO-2025
- Keywords
- COPD, Chronic Obstructive Pulmonary disease, mMRC, dyspnea, CAT, Interleukin-6, Probiotics, probiotic supplement
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Collaborators
- Abela Pharmaceuticals, Inc.
- Study start
- 8 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blinded
| Arm | Type | Receives |
|---|---|---|
| Probiotic arm | Active comparator | Dietary Supplement: Probiotic CapsuleParticipants will receive two capsules once daily of a probiotic dietary supplement for 16 weeks. The product will be coded to ensure blinding. |
| Placebo arm | Placebo comparator | Dietary Supplement: placebo capsuleParticipants will receive two capsules once daily of a placebo preparation for 16 weeks. The product will be coded to ensure blinding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic CapsuleAlso: Lactobacillus plantarum, Lac.plantarum HEAL9, Lac.plantarum LP 6596, Saccharomyces boulardiiThe 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. | Dietary supplement | Probiotic arm |
| placebo capsuleAlso: placebo, placebo controlParticipants 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. | Dietary supplement | Placebo arm |
Primary outcome
mMRC scale of dyspnea
Time frame: 8 weeks
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.
18 secondary outcomes
CAT questionnaire
Time frame: 8, 16 weeks
Bristol stool scale
Time frame: 8, 16 weeks
mMRC
Time frame: 4,12,16 weeks
IL-6
Time frame: 8 weeks
Complete blood count
Time frame: 8 and 16 weeks
Fibrinogen
Time frame: 8 and 16 weeks
CRP
Time frame: 8 and 16 weeks
Metabolic blood parameters-glucose
Time frame: 8, 16 weeks
Metabolic blood parameters-urea
Time frame: 8, 16 weeks
Metabolic blood parameters-creatinine
Time frame: 8, 16 weeks
Metabolic blood parameters-liver enzymes
Time frame: 8, 16 weeks
Metabolic blood parameters-electrolytes
Time frame: 8, 16 weeks
Metabolic blood parameters-lipid profile
Time frame: 8, 16 weeks
Lung function
Time frame: 16 weeks
Acute exacerbations
Time frame: 16 weeks
Correlation IL-6 and CRP
Time frame: 8 weeks
Other correlations
Time frame: 16 weeks
BMI
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 28495687Koblizek 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.
- Background: PubMed 10377201Bestall 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.
- Background: PubMed 35567889Karim 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.
- Background: PubMed 39324058Su 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.
- Background: PubMed 39280360Patibandla 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.
- Background: PubMed 27079636Panahi 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.
- Background: PubMed 40020522Aghamohammadi 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.
- Background: PubMed 35735170Ertan 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.
- Background: PubMed 14999112Celli 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.
- Background: PubMed 12006425Nishimura 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.
- Background: PubMed 37332470Sethi 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.
- BackgroundKantatong 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/
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves sensitive health information, and data sharing is not covered by the informed consent form or approved by the ethics committee. Only aggregated, anonymized study results will be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Capsule in people with COPD and COPD (Chronic Obstructive Pulmonary Disease), run by University Hospital of Split at 5 sites in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mMRC scale of dyspnea (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07339280, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.