Chronic Obstructive Pulmonary DiseaseNCT05523180
A Study to Evaluate the Effect of Probiotic Supplement on Quality of Life
A study testing Probiotic in people with Chronic Obstructive Pulmonary Disease and Non-cystic Fibrosis Bronchiectasis, run by ResBiotic Nutrition, Inc. at 2 sites in United States.
Trial summary
This study aims to evaluate the impact of a specific oral probiotic blend on the quality of life of adults with respiratory conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2022to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants who are 18-80 years of age (inclusive).
- Have been diagnosed with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis and have been on a stable treatment regimen for ≥ 6 months at screening.
- Have a body mass index between 18.0-34.9 kg/m2 (inclusive).
- Have normal or acceptable to the investigator vital signs (blood pressure, respiratory rate, heart rate) and normal or acceptable to the investigator physical exam findings (if applicable) at screening.
- Individuals of childbearing potential must agree to practice a medically acceptable form of birth control for a certain time frame prior to the first dose of study product and throughout the study, including:
- use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), or hormone implant (e.g., Norplant System)
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- use for at least 1 month prior to the first dose of study product: double-barrier method, intrauterine devices, or complete abstinence from sexual intercourse that can result in pregnancy
- vasectomy of partner at least 6 months prior to the first dose of study product Individuals with potential to impregnate others must agree to use condom or other medically acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that can result in pregnancy is also acceptable.
- Agree to refrain from treatments listed in the protocol in the defined timeframe.
- Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Who cannot join
- Participant has a history of heart disease, uncontrolled high blood pressure (i.e., ≥160 mmHg systolic or ≥100 mmHg diastolic), renal or hepatic impairment/disease, or uncontrolled diabetes (Type I or Type II) defined as not taking a stable dose of diabetes mellitus medication on the current regimen for a minimum of three months.
- Participants on oxygen therapy.
- Received a vaccine for COVID-19 in the 2 weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis).
- Participant has a history of unstable thyroid disease, immune disorders and/or immunocompromised (e.g. HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening visit.
- Major surgery in 3 months prior to screening or planned major surgery during the course of the study.
- Participant has consumed probiotic supplements and is unwilling to stop at least one week prior to screening and throughout the study. Supplemental probiotics may include standalone probiotic supplements, vitamins with probiotics, and any foods supplemented with probiotics.
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- Participant is currently being prescribed antibiotics or states that they have been prescribed antibiotics within the 3 months prior to screening.
- Participant has consumed supplemental enzymes and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental enzymes may include standalone enzyme supplements, probiotic supplements with enzymes, and any medications containing enzymes.
- Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g. known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis).
- Participants who are lactating, pregnant or planning to become pregnant during the study.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or any of the rescue medications.
- Receipt or use of an investigational product in another research study within 28 days prior to baseline visit.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Coral Research Clinic Corp.
Miami, Florida, 33186
Premier Medical Associates
The Villages, Florida, 32162
About this study
Official title: A Prospective, Randomized, Double-blinded, Placebo-controlled Study Evaluating the Safety and Impact of resB® Lung Support on Quality of Life in Adult Volunteers With Chronic Obstructive Pulmonary Disease or Non-cystic Fibrosis Bronchiectasis
This study aims to evaluate the impact of a specific oral probiotic blend on the quality of life of adults with respiratory conditions.
Read the detailed description
An imbalance and reduction of microbial diversity in the lung microbiota may negatively impact an individual's general health and quality of life. Further, individuals with respiratory conditions may take medications that may alter gut microbiome, which can have a negative impact on outcomes and quality of life. Evidence has emerged that there are interactions between gut and lung microbiomes, demonstrating the opportunity of using oral probiotics to support a healthy gut and/or lung microbiome, and subsequently, the general health and quality of life in this population.
- Being tested
- Probiotic, Placebo
- Keywords
- COPD, NCFBE, Probiotic
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called resB® Lung Support
Active ingredients:
Lactobacillus plantarum RSB11, 5 Billion colony forming units (CFU) Lactobacillus acidophilus RSB12, 5 Billion CFU Lactobacillus rhamnosus RSB13, 5 Billion CFU Holy basil leaf extract, 42.0 mg Turmeric root extract, 30.0 mg Vasaka leaf extract, 48.0 mg
Inactive ingredients:
Microcrystalline Cellulose, Vegan Capsule (Hypromellose), Magnesium Stearate, Silicon Dioxide
PlaceboOther
Active ingredients:
N/A
Inactive ingredients:
Microcrystalline Cellulose, Vegan Capsule (Hypromellose), Magnesium Stearate, Silicon Dioxide
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 1 capsule of 15 Billion CFU proprietary probiotic blend with 120 mg herbal extracts, taken twice daily. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | 1 capsule of placebo, taken twice daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of resB® Lung Support on quality of life
Change from baseline in St. George's Respiratory Questionnaire. The total score summarizes the impact of the condition on overall health status where 100 indicates the worst possible health status and 0 indicates best possible health status
Measured: 12 weeks
Secondary outcomes (37)
To determine the effect of resB® Lung Support on lung microbiome
Change from baseline in gut microbiome as assessed by 16S rRNA analysis from sputum samples
Measured: 12 weeks
To determine the effect of resB® Lung Support on gut microbiome
Change from baseline in gut microbiome as assessed by 16S rRNA analysis from fecal samples
Measured: 12 weeks
To determine the effect of resB® Lung Support on serum short-chain fatty acids
Change from baseline in serum short-chain fatty acids
Measured: 12 weeks
To determine the effect of resB® Lung Support on stool short-chain fatty acids
Change from baseline in stool
Measured: 12 weeks
To determine the effect of resB® Lung Support on biomarkers of inflammation
Change from baseline in serum concentration of metalloproteinase 9
Measured: 12 weeks
To determine the effect of resB® Lung Support on biomarkers of inflammation
Change from baseline in serum concentration of tripeptide N-acetyl proline-glycine-proline
Measured: 12 weeks
To determine the effect of resB® Lung Support on biomarkers of inflammation
Change from baseline in serum concentration of high-sensitivity C-reactive protein
Measured: 12 weeks
To determine the effect of resB® Lung Support on biomarkers of inflammation
Change from baseline in serum concentration of pro-inflammatory cytokines
Measured: 12 weeks
To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
Heart rate measurement
Measured: 12 weeks
To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
Blood pressure measurement
Measured: 12 weeks
To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
Respiratory rate measurement
Measured: 12 weeks
To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
Weight measurement
Measured: 12 weeks
To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
Body mass index measurement
Measured: 12 weeks
Change in Hemoglobin levels after taking resB® Lung Support
Change in Hemoglobin levels after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resB® Lung Support
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Albumin after taking resB® Lung Support
Change in Albumin after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Total Protein after taking resB® Lung Support
Change in Total Protein after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Globulin after taking resB® Lung Support
Change in Globulin after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Reb Blood Cell (RBC) count after taking resB® Lung Support
Change in Reb Blood Cell (RBC) count after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in in Red Cell Distribution Width (RDW) after taking resB® Lung Support
Change in in Red Cell Distribution Width (RDW) after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) after taking resB® Lung Support
Change in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Mean Corpuscular Hemoglobin (MCH) after taking resB® Lung Support
Change in Mean Corpuscular Hemoglobin (MCH) after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Platelet count after taking resB® Lung Support
Change in Platelet count after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in White Blood Cell (WBC) count after taking resB® Lung Support
Change in White Blood Cell (WBC) count after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in White Blood Cell (WBC) differential after taking resB® Lung Support
Change in White Blood Cell (WBC) differential after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Urea after taking resB® Lung Support
Change in Urea after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Sodium after taking resB® Lung Support
Change in Sodium after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Potassium after taking resB® Lung Support
Change in Potassium after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Chloride after taking resB® Lung Support
Change in Chloride after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Creatinine after taking resB® Lung Support
Change in Creatinine after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Bilirubin-total after taking resB® Lung Support
Change in Bilirubin-total after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Alkaline Phosphatase after taking resB® Lung Support
Change in Alkaline Phosphatase after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Aspartate Aminotransferase (AST) after taking resB® Lung Support
Change in Aspartate Aminotransferase (AST) after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Alanine Aminotransferase (ALT) after taking resB® Lung Support
Change in Alanine Aminotransferase (ALT) after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Change in Estimated Glomerular Filtration Rate (eGFR) after taking resB® Lung Support
Change in Estimated Glomerular Filtration Rate (eGFR) after taking resB® Lung Support compared to baseline
Measured: 12 weeks
Safety- participants experiencing adverse events
The number of participants experiencing Treatment Emergent Adverse Events (TEAEs)
Measured: 12 weeks
Safety- adverse events
The total number Treatment Emergent Adverse Events (TEAEs)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Sep 2022
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization at 1:1 ratio for active or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResBiotic Nutrition, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Anthony Bier, MD, Study director, Nutrasource Pharmaceutical and Nutraceutical Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523180
- Sponsor's protocol ID
- R01-21-02-T0027
- Status last verified
- Jun 2024
- First submitted
- 22 Aug 2022
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nicola T, Wenger NM, Seidman K, Evans M, Yang Y, Chen D, Van Der Pol WJ, Walia A, Lefkowitz EJ, Wang J, LeMoire A, Lin L, Morrow C, Ambalavanan N, Gaggar A, Lal CV. Double-Blind Randomized Placebo-Controlled Trial of a Lactobacillus Probiotic Blend in Chronic Obstructive Pulmonary Disease. Pulm Ther. 2026 Mar;12(1):251-263. doi: 10.1007/s41030-025-00333-y. Epub 2025 Nov 18.
PubMed 41254308
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blinded, Placebo-controlled Study Evaluating the Safety and Impact of resB® Lung Support on Quality of Life in Adult Volunteers With Chronic Obstructive Pulmonary Disease or Non-cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT05523180
- Acronym / sponsor ID
- R01-21-02-T0027
- Keywords
- COPD, NCFBE, Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ResBiotic Nutrition, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 31 Aug 2022 (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.
This study aims to evaluate the impact of a specific oral probiotic blend on the quality of life of adults with respiratory conditions.
Detailed description
An imbalance and reduction of microbial diversity in the lung microbiota may negatively impact an individual's general health and quality of life. Further, individuals with respiratory conditions may take medications that may alter gut microbiome, which can have a negative impact on outcomes and quality of life. Evidence has emerged that there are interactions between gut and lung microbiomes, demonstrating the opportunity of using oral probiotics to support a healthy gut and/or lung microbiome, and subsequently, the general health and quality of life in this population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomization at 1:1 ratio for active or placebo
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic1 capsule of 15 Billion CFU proprietary probiotic blend with 120 mg herbal extracts, taken twice daily. |
| Placebo | Placebo comparator | Other: Placebo1 capsule of placebo, taken twice daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult participants who are 18-80 years of age (inclusive).
- Have been diagnosed with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis and have been on a stable treatment regimen for ≥ 6 months at screening.
- Have a body mass index between 18.0-34.9 kg/m2 (inclusive).
- Have normal or acceptable to the investigator vital signs (blood pressure, respiratory rate, heart rate) and normal or acceptable to the investigator physical exam findings (if applicable) at screening.
- Individuals of childbearing potential must agree to practice a medically acceptable form of birth control for a certain time frame prior to the first dose of study product and throughout the study, including:
Key exclusion criteria (12 listed)
- Participant has a history of heart disease, uncontrolled high blood pressure (i.e., ≥160 mmHg systolic or ≥100 mmHg diastolic), renal or hepatic impairment/disease, or uncontrolled diabetes (Type I or Type II) defined as not taking a stable dose of diabetes mellitus medication on the current regimen for a minimum of three months.
- Participants on oxygen therapy.
- Received a vaccine for COVID-19 in the 2 weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis).
- Participant has a history of unstable thyroid disease, immune disorders and/or immunocompromised (e.g. HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening visit.
- Major surgery in 3 months prior to screening or planned major surgery during the course of the study.
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 |
|---|---|---|
| ProbioticAlso: resB® Lung SupportActive ingredients: Lactobacillus plantarum RSB11, 5 Billion colony forming units (CFU) Lactobacillus acidophilus RSB12, 5 Billion CFU Lactobacillus rhamnosus RSB13, 5 Billion CFU Holy basil leaf extract, 42.0 mg Turmeric root extract, 30.0 mg Vasaka leaf extract, 48.0 mg Inactive ingredients: Microcrystalline Cellulose, Vegan Capsule (Hypromellose), Magnesium Stearate, Silicon Dioxide | Dietary supplement | Probiotic |
| PlaceboActive ingredients: N/A Inactive ingredients: Microcrystalline Cellulose, Vegan Capsule (Hypromellose), Magnesium Stearate, Silicon Dioxide | Other | Placebo |
Primary outcome
To determine the effect of resB® Lung Support on quality of life
Time frame: 12 weeks
Change from baseline in St. George's Respiratory Questionnaire. The total score summarizes the impact of the condition on overall health status where 100 indicates the worst possible health status and 0 indicates best possible health status
37 secondary outcomes
To determine the effect of resB® Lung Support on lung microbiome
Time frame: 12 weeks
To determine the effect of resB® Lung Support on gut microbiome
Time frame: 12 weeks
To determine the effect of resB® Lung Support on serum short-chain fatty acids
Time frame: 12 weeks
To determine the effect of resB® Lung Support on stool short-chain fatty acids
Time frame: 12 weeks
To determine the effect of resB® Lung Support on biomarkers of inflammation
Time frame: 12 weeks
To determine the effect of resB® Lung Support on biomarkers of inflammation
Time frame: 12 weeks
To determine the effect of resB® Lung Support on biomarkers of inflammation
Time frame: 12 weeks
To determine the effect of resB® Lung Support on biomarkers of inflammation
Time frame: 12 weeks
To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
Time frame: 12 weeks
To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
Time frame: 12 weeks
To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
Time frame: 12 weeks
To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
Time frame: 12 weeks
To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
Time frame: 12 weeks
Change in Hemoglobin levels after taking resB® Lung Support
Time frame: 12 weeks
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resB® Lung Support
Time frame: 12 weeks
Change in Albumin after taking resB® Lung Support
Time frame: 12 weeks
Change in Total Protein after taking resB® Lung Support
Time frame: 12 weeks
Change in Globulin after taking resB® Lung Support
Time frame: 12 weeks
Change in Reb Blood Cell (RBC) count after taking resB® Lung Support
Time frame: 12 weeks
Change in in Red Cell Distribution Width (RDW) after taking resB® Lung Support
Time frame: 12 weeks
Change in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) after taking resB® Lung Support
Time frame: 12 weeks
Change in Mean Corpuscular Hemoglobin (MCH) after taking resB® Lung Support
Time frame: 12 weeks
Change in Platelet count after taking resB® Lung Support
Time frame: 12 weeks
Change in White Blood Cell (WBC) count after taking resB® Lung Support
Time frame: 12 weeks
Change in White Blood Cell (WBC) differential after taking resB® Lung Support
Time frame: 12 weeks
Change in Urea after taking resB® Lung Support
Time frame: 12 weeks
Change in Sodium after taking resB® Lung Support
Time frame: 12 weeks
Change in Potassium after taking resB® Lung Support
Time frame: 12 weeks
Change in Chloride after taking resB® Lung Support
Time frame: 12 weeks
Change in Creatinine after taking resB® Lung Support
Time frame: 12 weeks
Change in Bilirubin-total after taking resB® Lung Support
Time frame: 12 weeks
Change in Alkaline Phosphatase after taking resB® Lung Support
Time frame: 12 weeks
Change in Aspartate Aminotransferase (AST) after taking resB® Lung Support
Time frame: 12 weeks
Change in Alanine Aminotransferase (ALT) after taking resB® Lung Support
Time frame: 12 weeks
Change in Estimated Glomerular Filtration Rate (eGFR) after taking resB® Lung Support
Time frame: 12 weeks
Safety- participants experiencing adverse events
Time frame: 12 weeks
Safety- adverse events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Derived from this study: PubMed 41254308Nicola T, Wenger NM, Seidman K, Evans M, Yang Y, Chen D, Van Der Pol WJ, Walia A, Lefkowitz EJ, Wang J, LeMoire A, Lin L, Morrow C, Ambalavanan N, Gaggar A, Lal CV. Double-Blind Randomized Placebo-Controlled Trial of a Lactobacillus Probiotic Blend in Chronic Obstructive Pulmonary Disease. Pulm Ther. 2026 Mar;12(1):251-263. doi: 10.1007/s41030-025-00333-y. Epub 2025 Nov 18.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Anthony Bier, MD study director
Nutrasource Pharmaceutical and Nutraceutical Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Chronic Obstructive Pulmonary Disease and Non-cystic Fibrosis Bronchiectasis, run by ResBiotic Nutrition, Inc. at 2 sites in United States.
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 10 inclusion and 12 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: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the effect of resB® Lung Support on quality of life (time frame: 12 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 NCT05523180, which also lists 1 linked publication.
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 5 Jun 2024.