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NCT05949255 · ClinicalTrials.gov registry record · NA
Probiotics and Insulin Resistance in Obese Asthmatics
A NA study of Obesity and Asthma, sponsored by University of Alabama at Birmingham.
- Active
- Registry status
- NA
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT05949255: Active NA study of Obesity and Asthma, sponsored by University of Alabama at Birmingham.
NCT05949255 is a NA study of Obesity and Asthma that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 7 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05949255, a NA study of Obesity and Asthma, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
In this pilot study investigators will test the hypothesis that administration of oral probiotics modulates microbiome/metabolome, lowers leptin and insulin resistance and improves clinical parameters of asthma in obese insulin resistant asthmatics. Preliminary studies with oral probiotic administration in obese asthmatics showed increased abundance of probiotics-derived Bifidobacterium species and Bifidobacterium-derived metabolite in the airways of asthmatics. Additionally, neutrophils and IL-17 producing Th17 cells were significantly reduced following probiotics administration. Based on these preliminary studies, the investigators propose to test the following aims: Specific Aim 1: Determine if probiotic administration modulates airway microbiome/metabolome in obese insulin resistant asthmatics Specific Aim 2: Determine if modulation of leptin levels and insulin sensitivity by probiotics administration correlates with airway metabolome alterations and weight loss in obese insulin resistant asthmatics Specific Aim 3: Determine if microbiome/metabolome changes in probiotics group correlates with changes in asthma biomarkers and improved clinical outcomes compared to placebo in obese insulin resistant asthmatics.
Primary Outcome
(1a) For airway microbiome analyses, nasal wash samples will be used as surrogates. Nasal wash will be collected from subjects at baseline and 12 weeks. Rectal swab will be collected using Fecal swab kit (COPAN, Thermofisher) and samples prepared for microbiome analysis as above. Microbial genomic DNA from the samples will be isolated using the DNA isolation kit from Zymo Research. (1b) The samples obtained in Aim 1a will be used for metabolomics analyses, both gut and airway samples. Untargete
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Probiotic
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What the registry record for NCT05949255 still lists
NCT05949255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05949255 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT05949255 about?
NCT05949255 is a clinical study titled "Probiotics and Insulin Resistance in Obese Asthmatics". In this pilot study investigators will test the hypothesis that administration of oral probiotics modulates microbiome/metabolome, lowers leptin and insulin resistance and improves clinical parameters of asthma in obese insulin resistant asthmatics. Preliminary studies with oral probiotic administra...
What is the current status of trial NCT05949255?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 7 participants. The study started on 2024-04-01. Estimated completion is 2026-06-30.
What conditions does trial NCT05949255 study?
This clinical trial studies the following conditions: Obesity, Asthma, Insulin Resistance.
What interventions are being tested in trial NCT05949255?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Probiotic (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05949255?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05949255 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05949255's enrollment target sits among peer trials
7 1045th of 1053 higher than 7 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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