A Pilot Study to Assess the Safety Profile of resB®

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

Study Overview

• Status: Completed
• Conditions: Healthy; Asthma
• Intervention / Treatment: Dietary supplement: Probiotic Dietary Supplement

Detailed Description

resB® Lung Support is a probiotic dietary supplement that contains 3 probiotic strains and 3 herbal extracts: turmeric, holy basil, and vasaka. The proprietary herbal and probiotic blend is formulated to support proper lung structure and function. The study investigates the safety and tolerability of twice-daily supplementation of resB® Lung Support in asthma patients and healthy participants for 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork
    • Blackpool, Cork, Ireland
      • Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Retail Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be able to give written informed consent.
2. Be between 18 - 65 years.
3. Has a stable body weight (≤5 % change) over the past 3-months.
4. Is in general good health, as determined by the investigator.
5. Avoid consuming probiotics within 12 weeks prior to baseline visit, until the end of the trial.
6. 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.
7. Maintain current level of physical activity.
8. Willing to consume the investigational product daily for the duration of the trial.

Exclusion Criteria:

1. Are less than 18 or greater than 65.
2. Participants who are pregnant, breastfeeding, or wish to become pregnant during the trial.

3. Participants currently of child-bearing potential, but not using an effective method of contraception, as outlined below:

   1. 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).
   2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
   3. Sexual partner(s) is/are exclusively female.
   4. 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.
   5. 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.
4. Are hypersensitive or known allergy to any of the components of the investigational product.
5. Has taken antibiotics within the previous 12 weeks.
6. Has taken probiotics within the previous 12 weeks.
7. Has taken oral steroids (>10 mg/day) for more than 3 days in the previous 12 weeks.
8. Taking any immunosuppressive medications which in the opinion of the investigator are likely to have an impact on the outcomes of the trial.
9. Has made any major dietary changes in the 30 days prior to enrolment.
10. Change in medications or supplements in the 30 days prior to enrolment.
11. Have an acute or chronic illness (e.g., heart disease, inflammatory bowel disease, cancer, HIV) that, in the Investigators judgment, precludes involvement in the study
12. No more than 2 hospital admissions in the previous 6 months asthma population)
13. Presence of the following in a urine drug screen- Amphetamine/Ecstasy; Benzodiazepines; 6-Monoacetyl Morphine (6-MAM); Cocaine; Creatinine; EDDP; Opiates; Tricyclic Antidepressants; pH Detect
14. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
15. Participants may not be receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 3-months prior to this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Probiotic Dietary Supplement; resB® Lung Support - 1 capsule 2x daily for 4 weeks	Dietary supplement: Probiotic Dietary Supplement; Probiotic dietary supplement containing 3 probiotic strains and 3 herbal extracts; Other Names: resB® Lung Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
St George's Respiratory Questionnaire (SGRQ)	Change in SGRQ total score	0-4 weeks
Gut microbiota	Change in gut microbiota (16s sequencing)	0-4 weeks
Serum MMP-9	Change in serum Matrix Metallopeptidase-9 (MMP-9)	0-4 weeks
Cytokines (IL-1ß, IL-6, IL-8 & TNF-α)	Change in inflammatory cytokines (IL-1ß, IL-6, IL-8 & TNF-α)	0-4 weeks
Serum Vitamin D	Change in serum vitamin D (ng/mL)	0-4 weeks
Lung function	Change in lung function measured by spirometry (Forced Expired Volume in 1 second [FEV2]/Forced Vital Capacity [FVC])	0-4 weeks
Oxygen levels	Change in oxygen levels (% percentage pulse oxygen levels)	0-4 weeks

Collaborators and Investigators

• Sponsor: ResBiotic Nutrition, Inc.
• Collaborators: Atlantia Food Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 23, 2021
• Primary Completion (ACTUAL): January 20, 2022
• Study Completion (ACTUAL): January 20, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (ACTUAL): December 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: RESB101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No