A Study to Evaluate the Effect of Probiotic Supplement on Quality of Life

NCT ID: NCT05523180

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-09-12

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.

Conditions

Chronic Obstructive Pulmonary Disease; Non-cystic Fibrosis Bronchiectasis

Study Design

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

Study Groups

Probiotic

1 capsule of 15 Billion CFU proprietary probiotic blend with 120 mg herbal extracts, taken twice daily.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

1 capsule of placebo, taken twice daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Active ingredients:

N/A

Inactive ingredients:

Microcrystalline Cellulose, Vegan Capsule (Hypromellose), Magnesium Stearate, Silicon Dioxide

Interventions

Probiotic

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Active ingredients:

N/A

Inactive ingredients:

Microcrystalline Cellulose, Vegan Capsule (Hypromellose), Magnesium Stearate, Silicon Dioxide

Intervention Type: OTHER

Other Intervention Names

resB® Lung Support

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

NETWORK

Sponsor Role: collaborator

ResBiotic Nutrition, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Bier, MD

Role: STUDY_DIRECTOR

Nutrasource Pharmaceutical and Nutraceutical Services

Locations

Coral Research Clinic Corp.

Miami, Florida, United States

Premier Medical Associates

The Villages, Florida, United States

Countries

United States

Other Identifiers

R01-21-02-T0027

Identifier Type: -

Identifier Source: org_study_id