A Pilot Study to Assess the Safety Profile of resB®

Healthy Clinical Trial

Official title:

A Pilot Study to Assess the Safety Profile of resB®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05173168
• Other study ID #: RESB101
• Status: Completed
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: January 20, 2022

Study information

• Verified date: April 2022
• Source: ResBiotic, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Healthy

Intervention

Dietary Supplement:
• Probiotic Dietary Supplement
Probiotic dietary supplement containing 3 probiotic strains and 3 herbal extracts

Locations

Country	Name	City	State
Ireland	Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Retail Park	Blackpool	Cork

Sponsors (2)

Lead Sponsor	Collaborator
ResBiotic, Inc	Atlantia Food Clinical Trials

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	St George's Respiratory Questionnaire (SGRQ)	Change in SGRQ total score	0-4 weeks
Other	Gut microbiota	Change in gut microbiota (16s sequencing)	0-4 weeks
Other	Serum MMP-9	Change in serum Matrix Metallopeptidase-9 (MMP-9)	0-4 weeks
Other	Cytokines (IL-1ß, IL-6, IL-8 & TNF-a)	Change in inflammatory cytokines (IL-1ß, IL-6, IL-8 & TNF-a)	0-4 weeks
Other	Serum Vitamin D	Change in serum vitamin D (ng/mL)	0-4 weeks
Other	Lung function	Change in lung function measured by spirometry (Forced Expired Volume in 1 second [FEV2]/Forced Vital Capacity [FVC])	0-4 weeks
Other	Oxygen levels	Change in oxygen levels (% percentage pulse oxygen levels)	0-4 weeks
Primary	Number of participants experiencing at least one adverse event (AE)		0-4 weeks
Primary	Number of AEs including causality, severity, and seriousness assessments		0-4 weeks
Primary	Number of participants with discontinuations due to AEs		0-4 weeks
Primary	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
Primary	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