Probiotics for Obese Asthmatics with Insulin Resistance

N/A

Waitlist Available

Led By Jessy Deshane, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

All patients will be obese asthmatics with a body mass index >30 and insulin resistance >5

Must not have

Inability to understand study procedures and/or provide informed consent

Comorbid lung diseases other than asthma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial will test if oral probiotics help improve asthma symptoms in obese insulin resistant people.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, probiotics are generally considered safe but may cause digestive discomfort such as gas or bloating in some people.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I understand the study procedures and can give informed consent.

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I have a lung condition that is not asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Determine if probiotic administration modulates airway microbiome/metabolome in obese insulin resistant asthmatics