A Pilot Study to Assess the Safety Profile of resB®

NCT05173168 | Completed

• 1 other identifier: RESB101
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates the safety and tolerability of 4-week, twice daily supplementation of resB® Lung Support in asthma patients and healthy participants.

Conditions

Healthy; Asthma

Outcome Measures

Primary Outcomes (5)

• Number of participants experiencing at least one adverse event (AE)

  0-4 weeks

• Number of AEs including causality, severity, and seriousness assessments

  0-4 weeks

• Number of participants with discontinuations due to AEs

  0-4 weeks

• Number of participants with clinically significant changes in vital signs as a measure of safety

  Number of participants with clinically significant changes in vital signs including systolic blood pressure (mmHg), diastolic blood pressure (mmHg), heart rate (BPM), and body temperature will be reported.

  Baseline, Week 2, Week 4

• Number of participants with clinical laboratory abnormalities as a measure of safety

  Number of participants with clinical laboratory abnormalities (clinical laboratory tests include the following: hematology panel, serum chemistry panel) will be reported.

  Baseline, Week 2, Week 4

Other Outcomes (7)

• St George's Respiratory Questionnaire (SGRQ)

  0-4 weeks

• Gut microbiota

  0-4 weeks

• Serum MMP-9

  0-4 weeks

Study Arms (1)

Probiotic Dietary Supplement

EXPERIMENTAL

resB® Lung Support - 1 capsule 2x daily for 4 weeks

Dietary Supplement: Probiotic Dietary Supplement

Interventions

Probiotic Dietary Supplement DIETARY_SUPPLEMENT

Probiotic dietary supplement containing 3 probiotic strains and 3 herbal extracts

Also known as: resB® Lung Support

Probiotic Dietary Supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to give written informed consent.
• Be between 18 - 65 years.
• Has a stable body weight (≤5 % change) over the past 3-months.
• Is in general good health, as determined by the investigator.
• Avoid consuming probiotics within 12 weeks prior to baseline visit, until the end of the trial.
• Has asthma and on stable medication for at least 3 months (confirmed by prescribed medication) AND/OR be general good health at the discretion of the investigator.
• Maintain current level of physical activity.
• Willing to consume the investigational product daily for the duration of the trial.

You may not qualify if:

• Are less than 18 or greater than 65.
• Participants who are pregnant, breastfeeding, or wish to become pregnant during the trial.
• Participants currently of child-bearing potential, but not using an effective method of contraception, as outlined below:
• Complete abstinence from intercourse two weeks prior to administration of the investigational product, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the investigational product in cases where participant discontinues the trial prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
• Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
• Sexual partner(s) is/are exclusively female.
• Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm) or contraceptive pill. The participant must be using this method for at least 1 week following the end of the trial.
• Use of any non-hormonal intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1 % per year. The participant must have the device inserted at least 2 weeks prior to the first Screening Visit, throughout the trial, and 2 weeks following the end of the trial.
• Are hypersensitive or known allergy to any of the components of the investigational product.
• Has taken antibiotics within the previous 12 weeks.
• Has taken probiotics within the previous 12 weeks.
• Has taken oral steroids (\>10 mg/day) for more than 3 days in the previous 12 weeks.
• Taking any immunosuppressive medications which in the opinion of the investigator are likely to have an impact on the outcomes of the trial.
• Has made any major dietary changes in the 30 days prior to enrolment.
• Change in medications or supplements in the 30 days prior to enrolment.

Sponsors & Collaborators

• ResBiotic Nutrition, Inc.: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Retail Park

Blackpool, Cork, Ireland

Location

Related Publications (1)

• Wenger NM, Qiao L, Nicola T, Nizami Z, Martin I, Halloran BA, Tanaka K, Evans M, Xu X, Dinan TG, Kakilla C, DunnGalvin G, Ambalavanan N, Willis KA, Gaggar A, Lal CV. Clinical trial of a probiotic and herbal supplement for lung health. Front Nutr. 2023 Jun 13;10:1168582. doi: 10.3389/fnut.2023.1168582. eCollection 2023.

  PMID: 37384109 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Timothy Dinan

  Atlantia Food Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 29, 2021
• Study Start: November 23, 2021
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

IE (1)