Probiotics for Obese Asthmatics with Insulin Resistance

Recruiting in Palo Alto (17 mi)

Overseen by Jessy S Deshane, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for obese adults over 18 with asthma and insulin resistance. Participants must have a BMI >30, stable asthma without medication changes for 3 months, and an insulin resistance score >5. It's not open to pregnant individuals or those who can't consent, have had recent severe asthma attacks or other lung diseases.

Inclusion Criteria

I am older than 18 years.

I am obese with a BMI over 30 and have insulin resistance greater than 5.

My asthma is stable and my medications haven't changed in the last 3 months.

Exclusion Criteria

I needed oral steroids for asthma for more than 3 days recently.

Other significant medical conditions based on discretion of PI

I was hospitalized for asthma within the last 3 months.

Treatment Details

Interventions

• Probiotic (Probiotics)

Trial Overview The study tests if oral probiotics can change the airway microbiome/metabolome in these patients, reduce leptin and insulin resistance levels, lead to weight loss, and improve asthma outcomes compared to a placebo.

Participant Groups

Group I: Probiotic Experimental Treatment 1 Intervention

Subjects will receive a probiotic supplement to take by mouth daily.

Group II: Placebo Placebo Group 1 Intervention

Subjects will receive a placebo to take by mouth daily.

Probiotic is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

🇺🇸 Approved in United States as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

🇨🇦 Approved in Canada as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alabama at Birmingham Birmingham, AL

Who Is Running the Clinical Trial?

University of Alabama at Birmingham Lead Sponsor

American Lung Association Collaborator

References