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NCT05949255Active, not recruiting

Probiotics and Insulin Resistance in Obese Asthmatics

Source: ClinicalTrials.gov · Last updated 16 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
7 (actual)
First submitted
29 Jun 2023
Start date
1 Apr 2024
Primary completion date
30 Jun 2026
Lead sponsor
University of Alabama at Birmingham
Diseases
Obesity, Asthma
NCT number
NCT05949255

What you commit to

  • Study type: Interventional
  • Participants enrolled: 7
  • From 1 Apr 2024 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Asthma exacerbation requiring \>3 days of oral corticosteroids within 28 days of enrollment

Other illness

  • Comorbid lung diseases other than asthma
  • Other significant medical conditions based on discretion of PI

Other

  • Asthma related hospitalization within 90 days of enrollment
  • Pregnancy or planned pregnancy
  • Inability to understand study procedures and/or provide informed consent

Criteria the registry did not label

  • 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

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.