HealthyNCT05173168
A Pilot Study to Assess the Safety Profile of resB®
A study testing Probiotic Dietary Supplement in people with Healthy and Asthma, run by ResBiotic Nutrition, Inc. at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Probiotic Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIreland
- Study dates
- 23 Nov 2021to 20 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Retail Park
Blackpool, Cork
About this study
The study investigates the safety and tolerability of 4-week, twice daily supplementation of resB® Lung Support in asthma patients and healthy participants.
Read the 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.
- Being tested
- Probiotic Dietary Supplement
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Dietary SupplementDietary supplement
Also called resB® Lung Support
Probiotic dietary supplement containing 3 probiotic strains and 3 herbal extracts
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Dietary Supplement | Experimental | resB® Lung Support - 1 capsule 2x daily for 4 weeks Receives: Dietary Supplement: Probiotic Dietary Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing at least one adverse event (AE)
Measured: 0-4 weeks
Number of AEs including causality, severity, and seriousness assessments
Measured: 0-4 weeks
Number of participants with discontinuations due to AEs
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start23 Nov 2021
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResBiotic Nutrition, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, Principal investigator, Atlantia Food Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173168
- Sponsor's protocol ID
- RESB101
- Status last verified
- Apr 2022
- First submitted
- 16 Nov 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37384109
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Safety Profile of resB®
- ClinicalTrials.gov ID
- NCT05173168
- Acronym / sponsor ID
- RESB101
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- ResBiotic Nutrition, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the safety and tolerability of 4-week, twice daily supplementation of resB® Lung Support in asthma patients and healthy participants.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic Dietary Supplement | Experimental | Dietary Supplement: Probiotic Dietary SupplementresB® Lung Support - 1 capsule 2x daily for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
- Are hypersensitive or known allergy to any of the components of the investigational product.
- Has taken antibiotics within the previous 12 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Dietary SupplementAlso: resB® Lung SupportProbiotic dietary supplement containing 3 probiotic strains and 3 herbal extracts | Dietary supplement | Probiotic Dietary Supplement |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Derived from this study: PubMed 37384109Wenger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Dinan principal investigator
Atlantia Food Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Dietary Supplement in people with Healthy and Asthma, run by ResBiotic Nutrition, Inc. at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing at least one adverse event (AE) (time frame: 0-4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05173168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.