Probiotics and Insulin Resistance in Obese Asthmatics

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Asthma, Obesity, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT05949255

Run by

University of Alabama at Birmingham

People needed

7

Starts

2024-04-01

Expected to finish

2026-06-30

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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