A Pilot Study to Assess the Safety Profile of resB®
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|ClinicalTrials.gov Identifier: NCT05173168|
Recruitment Status : Completed
First Posted : December 29, 2021
Last Update Posted : April 29, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Healthy Asthma||Dietary Supplement: Probiotic Dietary Supplement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Assess the Safety Profile of resB®|
|Actual Study Start Date :||November 23, 2021|
|Actual Primary Completion Date :||January 20, 2022|
|Actual Study Completion Date :||January 20, 2022|
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 Name: resB® Lung Support
- Number of participants experiencing at least one adverse event (AE) [ Time Frame: 0-4 weeks ]
- Number of AEs including causality, severity, and seriousness assessments [ Time Frame: 0-4 weeks ]
- Number of participants with discontinuations due to AEs [ Time Frame: 0-4 weeks ]
- Number of participants with clinically significant changes in vital signs as a measure of safety [ Time Frame: Baseline, Week 2, Week 4 ]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.
- Number of participants with clinical laboratory abnormalities as a measure of safety [ Time Frame: Baseline, Week 2, Week 4 ]Number of participants with clinical laboratory abnormalities (clinical laboratory tests include the following: hematology panel, serum chemistry panel) will be reported.
- St George's Respiratory Questionnaire (SGRQ) [ Time Frame: 0-4 weeks ]Change in SGRQ total score
- Gut microbiota [ Time Frame: 0-4 weeks ]Change in gut microbiota (16s sequencing)
- Serum MMP-9 [ Time Frame: 0-4 weeks ]Change in serum Matrix Metallopeptidase-9 (MMP-9)
- Cytokines (IL-1ß, IL-6, IL-8 & TNF-α) [ Time Frame: 0-4 weeks ]Change in inflammatory cytokines (IL-1ß, IL-6, IL-8 & TNF-α)
- Serum Vitamin D [ Time Frame: 0-4 weeks ]Change in serum vitamin D (ng/mL)
- Lung function [ Time Frame: 0-4 weeks ]Change in lung function measured by spirometry (Forced Expired Volume in 1 second [FEV2]/Forced Vital Capacity [FVC])
- Oxygen levels [ Time Frame: 0-4 weeks ]Change in oxygen levels (% percentage pulse oxygen levels)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
- 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
- No more than 2 hospital admissions in the previous 6 months asthma population)
- 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05173168
|Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Retail Park|
|Blackpool, Cork, Ireland|
|Principal Investigator:||Timothy Dinan||Atlantia Food Clinical Trials|
|Responsible Party:||ResBiotic Nutrition, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 29, 2021 Key Record Dates|
|Last Update Posted:||April 29, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|