Clinical trial NCT05523180: A Study to Evaluate the Effect of Probiotic Supplement on Quality of Life
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Non-cystic Fibrosis Bronchiectasis
Keywords: COPD
NCFBE
Probiotic
Lead sponsor: ResBiotic Nutrition, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2022-08-31
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization at 1:1 ratio for active or placebo
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Adult participants who are 18-80 years of age (inclusive).
2. 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.
3. Have a body mass index between 18.0-34.9 kg/m2 (inclusive).
4. 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.
5. 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:

   1. 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)
   2. 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
   3. 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.
6. Agree to refrain from treatments listed in the protocol in the defined timeframe.
7. 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:

1. 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.
2. Participants on oxygen therapy.
3. 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).
4. 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.
5. Major surgery in 3 months prior to screening or planned major surgery during the course of the study.
6. 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.
7. Participant is currently being prescribed antibiotics or states that they have been prescribed antibiotics within the 3 months prior to screening.
8. 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.
9. 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).
10. Participants who are lactating, pregnant or planning to become pregnant during the study.
11. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or any of the rescue medications.
12. Receipt or use of an investigational product in another research study within 28 days prior to baseline visit.

Primary outcomes:
measure: To determine the effect of resB® Lung Support on quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: To determine the effect of resB® Lung Support on lung microbiome
timeFrame: 12 weeks
measure: To determine the effect of resB® Lung Support on gut microbiome
timeFrame: 12 weeks
measure: To determine the effect of resB® Lung Support on serum short-chain fatty acids
timeFrame: 12 weeks
measure: To determine the effect of resB® Lung Support on stool short-chain fatty acids
timeFrame: 12 weeks
measure: To determine the effect of resB® Lung Support on biomarkers of inflammation
timeFrame: 12 weeks
measure: To determine the effect of resB® Lung Support on biomarkers of inflammation
timeFrame: 12 weeks
measure: To determine the effect of resB® Lung Support on biomarkers of inflammation
timeFrame: 12 weeks
measure: To determine the effect of resB® Lung Support on biomarkers of inflammation
timeFrame: 12 weeks
measure: To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
timeFrame: 12 weeks
measure: To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
timeFrame: 12 weeks
measure: To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
timeFrame: 12 weeks
measure: To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
timeFrame: 12 weeks
measure: To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis
timeFrame: 12 weeks
measure: Change in Hemoglobin levels after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Albumin after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Total Protein after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Globulin after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Reb Blood Cell (RBC) count after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in in Red Cell Distribution Width (RDW) after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Mean Corpuscular Hemoglobin (MCH) after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Platelet count after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in White Blood Cell (WBC) count after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in White Blood Cell (WBC) differential after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Urea after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Sodium after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Potassium after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Chloride after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Creatinine after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Bilirubin-total after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Alkaline Phosphatase after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Aspartate Aminotransferase (AST) after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Alanine Aminotransferase (ALT) after taking resB® Lung Support
timeFrame: 12 weeks
measure: Change in Estimated Glomerular Filtration Rate (eGFR) after taking resB® Lung Support
timeFrame: 12 weeks
measure: Safety- participants experiencing adverse events
timeFrame: 12 weeks
measure: Safety- adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Coral Research Clinic Corp.
state: Florida
city: The Villages
country: United States
facility: Premier Medical Associates
state: Florida
Study officials:
affiliation: Nutrasource Pharmaceutical and Nutraceutical Services
name: Anthony Bier, MD
role: STUDY_DIRECTOR
References: