- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05523180
A Study to Evaluate the Effect of Probiotic Supplement on Quality of Life
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33186
- Coral Research Clinic Corp.
-
The Villages, Florida, United States, 32162
- Premier Medical Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotic
1 capsule of 15 Billion CFU proprietary probiotic blend with 120 mg herbal extracts, taken twice daily.
|
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
Other Names:
|
Placebo Comparator: Placebo
1 capsule of placebo, taken twice daily.
|
Active ingredients: N/A Inactive ingredients: Microcrystalline Cellulose, Vegan Capsule (Hypromellose), Magnesium Stearate, Silicon Dioxide |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the effect of resB® Lung Support on lung microbiome
Time Frame: 12 weeks
|
Change from baseline in gut microbiome as assessed by 16S rRNA analysis from sputum samples
|
12 weeks
|
To determine the effect of resB® Lung Support on gut microbiome
Time Frame: 12 weeks
|
Change from baseline in gut microbiome as assessed by 16S rRNA analysis from fecal samples
|
12 weeks
|
To determine the effect of resB® Lung Support on serum short-chain fatty acids
Time Frame: 12 weeks
|
Change from baseline in serum short-chain fatty acids
|
12 weeks
|
To determine the effect of resB® Lung Support on stool short-chain fatty acids
Time Frame: 12 weeks
|
Change from baseline in stool
|
12 weeks
|
To determine the effect of resB® Lung Support on biomarkers of inflammation
Time Frame: 12 weeks
|
Change from baseline in serum concentration of metalloproteinase 9
|
12 weeks
|
To determine the effect of resB® Lung Support on biomarkers of inflammation
Time Frame: 12 weeks
|
Change from baseline in serum concentration of tripeptide N-acetyl proline-glycine-proline
|
12 weeks
|
To determine the effect of resB® Lung Support on biomarkers of inflammation
Time Frame: 12 weeks
|
Change from baseline in serum concentration of high-sensitivity C-reactive protein
|
12 weeks
|
To determine the effect of resB® Lung Support on biomarkers of inflammation
Time Frame: 12 weeks
|
Change from baseline in serum concentration of pro-inflammatory cytokines
|
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
|
Heart rate measurement
|
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
|
Blood pressure measurement
|
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
|
Respiratory rate measurement
|
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
|
Weight measurement
|
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
|
Body mass index measurement
|
12 weeks
|
Change in Hemoglobin levels after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Hemoglobin levels after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Albumin after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Albumin after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Total Protein after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Total Protein after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Globulin after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Globulin after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Reb Blood Cell (RBC) count after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Reb Blood Cell (RBC) count after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in in Red Cell Distribution Width (RDW) after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in in Red Cell Distribution Width (RDW) after taking resB® Lung Support compared to baseline
|
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 Volume (MCV) and Mean Platelet Volume (MPV) after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Mean Corpuscular Hemoglobin (MCH) after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Mean Corpuscular Hemoglobin (MCH) after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Platelet count after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Platelet count after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in White Blood Cell (WBC) count after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in White Blood Cell (WBC) count after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in White Blood Cell (WBC) differential after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in White Blood Cell (WBC) differential after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Urea after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Urea after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Sodium after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Sodium after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Potassium after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Potassium after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Chloride after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Chloride after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Creatinine after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Creatinine after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Bilirubin-total after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Bilirubin-total after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Alkaline Phosphatase after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Alkaline Phosphatase after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Aspartate Aminotransferase (AST) after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Aspartate Aminotransferase (AST) after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Alanine Aminotransferase (ALT) after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Alanine Aminotransferase (ALT) after taking resB® Lung Support compared to baseline
|
12 weeks
|
Change in Estimated Glomerular Filtration Rate (eGFR) after taking resB® Lung Support
Time Frame: 12 weeks
|
Change in Estimated Glomerular Filtration Rate (eGFR) after taking resB® Lung Support compared to baseline
|
12 weeks
|
Safety- participants experiencing adverse events
Time Frame: 12 weeks
|
The number of participants experiencing Treatment Emergent Adverse Events (TEAEs)
|
12 weeks
|
Safety- adverse events
Time Frame: 12 weeks
|
The total number Treatment Emergent Adverse Events (TEAEs)
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Anthony Bier, MD, Nutrasource Pharmaceutical and Nutraceutical Services
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01-21-02-T0027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on Probiotic
-
King's College Hospital NHS TrustCompleted
-
Fudan UniversityInner Mongolia Yili Industrial Group Co., LtdCompletedObesity | AdiposityChina
-
Centros de Investigación de Nutrición y SaludNutribioticaCompletedFunctional ConstipationSpain
-
Universiti Kebangsaan Malaysia Medical CentreUnknownHypertension | Obesity | Type 2 Diabetes Mellitus | HyperlipidemiaMalaysia
-
Maastricht University Medical CenterCompleted
-
Fundació Sant Joan de DéuCompleted
-
University of LeedsUnknown
-
Centro Pediatrico Albina de PatinoCompletedAcute Gastroenteritis | Acute DiarrheaBolivia
-
BiocodexCompletedAcute GastroenteritisArgentina
-
Deivis de Oliveira guimaraesCompletedParkinson Disease | Alzheimer DiseaseBrazil