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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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The study investigates the safety and tolerability of 4-week, twice daily supplementation of resB® Lung Support in asthma patients and healthy participants.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Dietary Supplement | Experimental | resB® Lung Support - 1 capsule 2x daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Dietary Supplement | Dietary Supplement | Probiotic dietary supplement containing 3 probiotic strains and 3 herbal extracts |
|
| 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 |
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| 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) |
Inclusion Criteria:
Exclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Dinan | Atlantia Food Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Retail Park | Blackpool | Cork | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37384109 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |