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Sponsor: University of Alabama at Birmingham
Conditions: Asthma, Obesity, Insulin Resistance
Interventions: Probiotic, Placebo
Countries: United States
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.
Sex: ALL
Age: 18 Years to 99 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
InclusionCriteria: * Age \> 18 years * All patients will be obese asthmatics. Patients will have a body mass index \>30 and insulin resistance\>5. * Asthmatics who have stable disease without changes to their asthma related medications for 3 months prior to enrollment Exclusion Criteria: * Asthma related hospitalization within 90 days of enrollment * Asthma exacerbation requiring \>3 days of oral corticosteroids within 28 days of enrollment * Comorbid lung diseases other than asthma * Pregnancy or planned pregnancy * Inability to understand study procedures and/or provide informed consent * Other significant medical conditions based on discretion of PI
- Birmingham, Alabama, United States