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

NCT05523180 | Completed

• 1 other identifier: R01-21-02-T0027
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease; Non-cystic Fibrosis Bronchiectasis

Keywords

COPD; NCFBE; Probiotic

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (37)

• To determine the effect of resB® Lung Support on lung microbiome

  12 weeks

• To determine the effect of resB® Lung Support on gut microbiome

  12 weeks

• To determine the effect of resB® Lung Support on serum short-chain fatty acids

  12 weeks

• To determine the effect of resB® Lung Support on stool short-chain fatty acids

  12 weeks

• To determine the effect of resB® Lung Support on biomarkers of inflammation

  12 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

1 capsule of placebo, taken twice daily.

Other: Placebo

Interventions

Probiotic 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

Also known as: resB® Lung Support

Probiotic

Placebo OTHER

Active ingredients: N/A Inactive ingredients: Microcrystalline Cellulose, Vegan Capsule (Hypromellose), Magnesium Stearate, Silicon Dioxide

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ResBiotic Nutrition, Inc.: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (2)

Coral Research Clinic Corp.

Miami, Florida, 33186, United States

Location

Premier Medical Associates

The Villages, Florida, 32162, United States

Location

Related Publications (1)

• 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. 2025 Nov 18. doi: 10.1007/s41030-025-00333-y. Online ahead of print.

  PMID: 41254308 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Anthony Bier, MD

  Nutrasource Pharmaceutical and Nutraceutical Services

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization at 1:1 ratio for active or placebo

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 31, 2022
• Study Start: September 1, 2022
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)