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NCT03157518 · ClinicalTrials.gov registry record · NA
Oral Probiotic Administration to Modulate the Airway Microbiome in Obese Asthmatic Subjects
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT03157518 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 4 participants.
The verdict
NCT03157518, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
Obesity is a major health concern in the Deep South resulting in a growing number of metabolic disorders that strain the resources of our healthcare system. Obesity is recognized as a major risk factor for asthma. The Centers for Disease Control and Prevention (CDC) has stated "obesity is associated significantly with the development of asthma, worsening asthma symptoms, and poor asthma control. This leads to increased medication use and hospitalizations." Variations in the airway microbiome are correlated with the risk for development of asthma, and populations of different bacteria vary by phenotype amongst severe asthmatics . Proteobacteria are found in greater proportion in asthmatic subjects relative to healthy controls (37% vs 15%) while non-asthmatic subjects have a relative abundance of Firmicutes (47% vs 63%) and Actinobacteria (10% vs 14%) compared to those with asthma . Amongst those with asthma, obese asthmatic subjects have a relative abundance of Bacteroides (54%) and Firmicutes (26%). Notably, both phyla are part of the gastrointestinal microbiome, suggesting inoculation through gastroesophageal reflux which may be more common in obese individuals. Asthmatics identified as having improvement in their asthma control following treatment with inhaled corticosteroids appear to have a greater relative abundance of Actinobacteria (79.8%) in their airways relative to other asthmatics. Actinobacteria have been associated with the production of anti-inflammatory proteins and are speculated to be involved in increasing steroid responsiveness. Other studies have demonstrated that oral administration of probiotics, including Bifidobacterium species within the phyla Actinobacteria, lead to reduced Th2 cytokine production and eosinophilic inflammation, along with promotion of Regulatory T-cell (Treg) populations within the airway. We hypothesize that administration of over the counter oral probiotics containing Actinobacteria (Bifidobacterium) to obese asthmatic s
Interventions
- DIETARY_SUPPLEMENT Seeking Health Probiota Bifido
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2018-06-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03157518
The ClinicalTrials.gov registry entry for NCT03157518 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Seeking Health Probiota Bifido is the first listed.
NCT03157518 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03157518 about?
NCT03157518 is a clinical study titled "Oral Probiotic Administration to Modulate the Airway Microbiome in Obese Asthmatic Subjects". Obesity is a major health concern in the Deep South resulting in a growing number of metabolic disorders that strain the resources of our healthcare system. Obesity is recognized as a major risk factor for asthma. The Centers for Disease Control and Prevention (CDC) has stated "obesity is associated...
What is the current status of trial NCT03157518?
This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2017-07-01. Estimated completion is 2018-06-18.
What interventions are being tested in trial NCT03157518?
The interventions under investigation include: Seeking Health Probiota Bifido (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03157518?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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