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Search / Trial NCT05949255

Probiotics and Insulin Resistance in Obese Asthmatics

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Jul 7, 2023

Trial Information

Current as of September 11, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This small, early-stage study at the University of Alabama at Birmingham is testing whether taking a daily probiotic capsule for 12 weeks can change the bacteria and chemicals in the airways and gut of adults who are obese and have asthma with insulin resistance. About 20 adults (age 18 or older, BMI over 30, insulin resistance by a HOMA-IR score greater than 5, and stable asthma) will be randomly assigned to receive either the probiotic or a placebo for 12 weeks. Neither the participants nor the researchers will know who is in which group during the study.

Participants will have tests at the start and end of the study, including fasting blood work to check glucose, leptin, fats, and insulin sensitivity, as well as measurements of weight and waist size. They will also undergo asthma assessments like lung function tests and questionnaires about symptoms and quality of life. In addition, nose and rectal samples will be collected to study the airway and gut bacteria and their related chemicals. The goal is to see if probiotics can modulate airway and gut ecosystems, relate those changes to insulin resistance and weight, and whether there are any improvements in asthma-related measures compared with placebo. The trial is being conducted in Birmingham, Alabama, and is designed to inform whether larger studies are warranted.

Gender

ALL

Eligibility criteria

  • 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

About University Of Alabama At Birmingham

The University of Alabama at Birmingham (UAB) is a prominent academic institution and research hub dedicated to advancing healthcare through innovative clinical trials. Renowned for its commitment to medical discovery and education, UAB conducts cutting-edge research across a wide array of disciplines, including oncology, cardiology, neurology, and public health. With a robust infrastructure for clinical research, UAB fosters collaboration among interdisciplinary teams, leveraging state-of-the-art facilities and resources to enhance the translation of scientific findings into effective treatments and interventions. As a leader in clinical research, UAB aims to improve patient outcomes and contribute to the broader medical community through rigorous trial design and implementation.

Locations

Birmingham, Alabama, United States

Patients applied

0 patients applied

Trial Officials

Jessy Deshane, PhD

Principal Investigator

University of Alabama at Birmingham

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported