AsthmaNCT05949255
Probiotics and Insulin Resistance in Obese Asthmatics
A study testing Probiotic in people with Asthma and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma, Obesity, Insulin Resistance
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 23 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
Read the detailed description
Participants for this study will be recruited through the UAB Asthma Clinic under an IRB approved protocol. The Asthma Clinic at UAB has over 350 unique patients. The composition of the clinic is 73% female, 58% non-hispanic white and 34% black/African American, and 63% have a BMI over 30. Asthma is defined by a constellation of symptoms including episodic dyspnea, cough, wheeze, and chest tightness with evidence of airway hyperresponsiveness. The subjects recruited to this study will be seen in the Asthma Clinic at UAB. All participants will have a clinical history of symptoms consistent with a diagnosis of asthma, and testing supporting the presence of airway hyperresponsiveness as denoted by either a positive bronchodilator response, a positive methacholine challenge test, or a high degree of clinical suspicion for asthma but unable to perform either of those tests. This study will recruit obese asthmatics with an Insulin Resistance score >5. Classification of obesity, waist circumference and waist-to-hip ratio (WHR) will be determined according to the WHO definitions. Body mass index (BMI kg/m2) of >30 will be considered obese. The Homeostatic model assessment (HOMA)-IR values >5 will be classified as those with severe IR. Additional patient information including age, sex, demographics and BMI will be collected at baseline and at 12 weeks. The HOMA-IR estimates steady-state β- cell function and insulin sensitivity and will be calculated by multiplying the fasting plasma glucose (mg/dl) value by serum insulin value (mIU/ml) value divided by 405. Potential participants will be prescreened for inclusion in this study. Patients in the Asthma Clinic who have previously agreed to participate in a local biorepository will have all of the prerequisite biometric data available, so only those individuals meeting inclusion criteria will be contacted for participation.
Participants (n=20 obese asthmatics) will be fasted for at least 12 hours prior to blood sampling at baseline. 20 obese asthmatic patients with BMI >30 and with IR >5 will be randomized and 10 patients will receive 1 capsule/day of 500 mg of probiotic supplement (Floragen Digestion, American Lifelines, Baraboo, WI ). This is a probiotic combination product ((Lactobacillus acidophilus, Bifidobacterium lactis, and Bifidobacterium longum (1.5 x 1010 CFUs/capsule)) and 10 patients in placebo group will receive 500 mg of starch per day for 12 weeks. For both study groups, both genders will be recruited equally with an anticipated distribution of approximately 40% African American and 60% Caucasian subjects. At baseline and at end of 12 weeks, respiratory function tests will be carried out and clinical endpoint measurements will be made. Additionally, nasal filters, nasal washes, rectal swabs, peripheral blood mononuclear cells and serum samples will be collected. 40 ml of peripheral blood samples will be collected at baseline and at 12 weeks after administration of probiotics or placebo control. These samples will be used for endpoint measurements in peripheral blood and serum. Microbiome analyses of nasal washes and rectal swabs will be carried out in collaboration with the UAB Microbiome core. For metabolomics studies, sampling of the upper airways of 60 participants with paired nasal filters and washes. The nasal filter method consists of introducing ~ 1/3 to 1/2 of a 15 × 25 mm filter paper made of synthetic absorptive matrix (Leukosorb, Pall Life Sciences) into one of the nostrils and placing it laterally against the anterior portion of the inferior nasal turbinate. The nasal filter will be left in the nostril for a minimum of 30 s and up to 2 min. Once removed, it will be placed into a sterile container. The nasal wash method consisted of using a bulb syringe to flush 3-5 mL of sterile, non-bacteriostatic, normal saline solution into the contralateral nostril. Both nasal filters and washes will be centrifuged and the supernatant transferred to a freezer and stored at - 80 °C until further processing.
- Conditions
- Asthma, Obesity, Insulin Resistance
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Asthma, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
10 subject will receive a probiotic daily for 12 weeks.
PlaceboDietary supplement
10 subjects will receive a placebo daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Subjects will receive a probiotic supplement to take by mouth daily. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Subjects will receive a placebo to take by mouth daily. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if probiotic administration modulates airway microbiome/metabolome in obese insulin resistant asthmatics
(1a) For airway microbiome analyses, nasal wash samples will be used as surrogates. Nasal wash will be collected from subjects at baseline and 12 weeks. Rectal swab will be collected using Fecal swab kit (COPAN, Thermofisher) and samples prepared for microbiome analysis as above. Microbial genomic DNA from the samples will be isolated using the DNA isolation kit from Zymo Research.
(1b) The samples obtained in Aim 1a will be used for metabolomics analyses, both gut and airway samples. Untargeted metabolomics utilizing Liquid Chromatography coupled with mass spectrometry will be performed at UAB Metabolomics Core and metabolites including SCFA, acetate, lactate, ethanol, succinate, formate and enterolactone will be analyzed and quantitated.
For both above aims, changes over the 12 weeks will be compared between groups.
Measured: 12 weeks
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
(2a) Classification of obesity, waist circumference and waist-to-hip ratio (WHR) will be determined according to the WHO definitions. At baseline and at 12 weeks post-probiotic administration, glucose, Leptin and lipid profile panels will be analyzed from plasma prepared from whole blood collected from fasting individuals.
(2b) The recruited subjects will have a HOMA-IR >5. At baseline and at 12 weeks after probiotics/placebo administration, potential change in insulin sensitivity will be calculated as described in methods above. (2c) Determine if probiotic-mediated changes in leptin, weight gain and insulin sensitivity correlates with airway metabolome alterations compared to placebo controls. Unique airway metabolome signatures comparing probiotics and placebo control groups will be correlated with lowered leptin levels, increased weight loss and increased insulin sensitivity.
For the above aims, changes over the 12 weeks will be compared between groups.
Measured: 12 weeks
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
(3a) At baseline and at 12 weeks post-probiotics or placebo administration, asthma biomarkers such as FeNO, IgE, peripheral neutrophils and eosinophils as well as proinflammatory plasma cytokines (IL-6, TNF-α, IL-1β) will be measured. Innate and adaptive immune cells will be enumerated by multiparameter flow cytometry in peripheral blood. These biomarkers will be correlated with changes in microbiome/metabolome identified above in Aim 1 between groups.
(3b) At baseline and at 12 weeks post-probiotics or placebo administration, spirometry (FEV1 and FVC), exacerbations/steroid exposure, asthma control test (ACT) and asthma control questionnaire, Asthma Quality of Life Questionnaire (AQLQ) will be performed. Comparison in differences will be made between the groups.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Apr 2024
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Why it stopped: Lost coordinator and statistician before no cost extension study could be completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association
- Responsible party
- Principal investigator, Jessy S. Deshane, University of Alabama at Birmingham
- Investigators
- Jessy Deshane, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949255
- Sponsor's protocol ID
- IRB-300011423
- Other IDs
- ALA 1143197
- Status last verified
- Nov 2026
- First submitted
- 29 Jun 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and Insulin Resistance in Obese Asthmatics
- ClinicalTrials.gov ID
- NCT05949255
- Acronym / sponsor ID
- IRB-300011423
- Conditions
- Asthma, Obesity, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lost coordinator and statistician before no cost extension study could be completed.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Lung Association
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants for this study will be recruited through the UAB Asthma Clinic under an IRB approved protocol. The Asthma Clinic at UAB has over 350 unique patients. The composition of the clinic is 73% female, 58% non-hispanic white and 34% black/African American, and 63% have a BMI over 30. Asthma is defined by a constellation of symptoms including episodic dyspnea, cough, wheeze, and chest tightness with evidence of airway hyperresponsiveness. The subjects recruited to this study will be seen in the Asthma Clinic at UAB. All participants will have a clinical history of symptoms consistent with a diagnosis of asthma, and testing supporting the presence of airway hyperresponsiveness as denoted by either a positive bronchodilator response, a positive methacholine challenge test, or a high degree of clinical suspicion for asthma but unable to perform either of those tests. This study will recruit obese asthmatics with an Insulin Resistance score >5. Classification of obesity, waist circumference and waist-to-hip ratio (WHR) will be determined according to the WHO definitions. Body mass index (BMI kg/m2) of >30 will be considered obese. The Homeostatic model assessment (HOMA)-IR values >5 will be classified as those with severe IR. Additional patient information including age, sex, demographics and BMI will be collected at baseline and at 12 weeks. The HOMA-IR estimates steady-state β- cell function and insulin sensitivity and will be calculated by multiplying the fasting plasma glucose (mg/dl) value by serum insulin value (mIU/ml) value divided by 405. Potential participants will be prescreened for inclusion in this study. Patients in the Asthma Clinic who have previously agreed to participate in a local biorepository will have all of the prerequisite biometric data available, so only those individuals meeting inclusion criteria will be contacted for participation.
Participants (n=20 obese asthmatics) will be fasted for at least 12 hours prior to blood sampling at baseline. 20 obese asthmatic patients with BMI >30 and with IR >5 will be randomized and 10 patients will receive 1 capsule/day of 500 mg of probiotic supplement (Floragen Digestion, American Lifelines, Baraboo, WI ). This is a probiotic combination product ((Lactobacillus acidophilus, Bifidobacterium lactis, and Bifidobacterium longum (1.5 x 1010 CFUs/capsule)) and 10 patients in placebo group will receive 500 mg of starch per day for 12 weeks. For both study groups, both genders will be recruited equally with an anticipated distribution of approximately 40% African American and 60% Caucasian subjects. At baseline and at end of 12 weeks, respiratory function tests will be carried out and clinical endpoint measurements will be made. Additionally, nasal filters, nasal washes, rectal swabs, peripheral blood mononuclear cells and serum samples will be collected. 40 ml of peripheral blood samples will be collected at baseline and at 12 weeks after administration of probiotics or placebo control. These samples will be used for endpoint measurements in peripheral blood and serum. Microbiome analyses of nasal washes and rectal swabs will be carried out in collaboration with the UAB Microbiome core. For metabolomics studies, sampling of the upper airways of 60 participants with paired nasal filters and washes. The nasal filter method consists of introducing ~ 1/3 to 1/2 of a 15 × 25 mm filter paper made of synthetic absorptive matrix (Leukosorb, Pall Life Sciences) into one of the nostrils and placing it laterally against the anterior portion of the inferior nasal turbinate. The nasal filter will be left in the nostril for a minimum of 30 s and up to 2 min. Once removed, it will be placed into a sterile container. The nasal wash method consisted of using a bulb syringe to flush 3-5 mL of sterile, non-bacteriostatic, normal saline solution into the contralateral nostril. Both nasal filters and washes will be centrifuged and the supernatant transferred to a freezer and stored at - 80 °C until further processing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticSubjects will receive a probiotic supplement to take by mouth daily. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects will receive a placebo to take by mouth daily. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic10 subject will receive a probiotic daily for 12 weeks. | Dietary supplement | Probiotic |
| Placebo10 subjects will receive a placebo daily for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Determine if probiotic administration modulates airway microbiome/metabolome in obese insulin resistant asthmatics
Time frame: 12 weeks
(1a) For airway microbiome analyses, nasal wash samples will be used as surrogates. Nasal wash will be collected from subjects at baseline and 12 weeks. Rectal swab will be collected using Fecal swab kit (COPAN, Thermofisher) and samples prepared for microbiome analysis as above. Microbial genomic DNA from the samples will be isolated using the DNA isolation kit from Zymo Research. (1b) The samples obtained in Aim 1a will be used for metabolomics analyses, both gut and airway samples. Untargeted metabolomics utilizing Liquid Chromatography coupled with mass spectrometry will be performed at UAB Metabolomics Core and metabolites including SCFA, acetate, lactate, ethanol, succinate, formate and enterolactone will be analyzed and quantitated. For both above aims, changes over the 12 weeks will be compared between groups.
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
Time frame: 12 weeks
(2a) Classification of obesity, waist circumference and waist-to-hip ratio (WHR) will be determined according to the WHO definitions. At baseline and at 12 weeks post-probiotic administration, glucose, Leptin and lipid profile panels will be analyzed from plasma prepared from whole blood collected from fasting individuals. (2b) The recruited subjects will have a HOMA-IR >5. At baseline and at 12 weeks after probiotics/placebo administration, potential change in insulin sensitivity will be calculated as described in methods above. (2c) Determine if probiotic-mediated changes in leptin, weight gain and insulin sensitivity correlates with airway metabolome alterations compared to placebo controls. Unique airway metabolome signatures comparing probiotics and placebo control groups will be correlated with lowered leptin levels, increased weight loss and increased insulin sensitivity. For the above aims, changes over the 12 weeks will be compared between groups.
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
Time frame: 12 weeks
(3a) At baseline and at 12 weeks post-probiotics or placebo administration, asthma biomarkers such as FeNO, IgE, peripheral neutrophils and eosinophils as well as proinflammatory plasma cytokines (IL-6, TNF-α, IL-1β) will be measured. Innate and adaptive immune cells will be enumerated by multiparameter flow cytometry in peripheral blood. These biomarkers will be correlated with changes in microbiome/metabolome identified above in Aim 1 between groups. (3b) At baseline and at 12 weeks post-probiotics or placebo administration, spirometry (FEV1 and FVC), exacerbations/steroid exposure, asthma control test (ACT) and asthma control questionnaire, Asthma Quality of Life Questionnaire (AQLQ) will be performed. Comparison in differences will be made between the groups.
Results and safety
The study was stopped early (reason given: Lost coordinator and statistician before no cost extension study could be completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessy Deshane, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Asthma and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lost coordinator and statistician before no cost extension study could be completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if probiotic administration modulates airway microbiome/metabolome in obese insulin resistant asthmatics (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.