Probiotics for Obese Asthmatics with Insulin Resistance

Overseen By Alexis Williams

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Comorbid lung diseases, Pregnancy, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily probiotics can improve asthma symptoms in individuals who are both obese and have insulin resistance, a condition where the body doesn't use insulin effectively. Researchers aim to determine if probiotics, which are beneficial bacteria, can alter the bacterial mix in the airways, reduce insulin resistance, and aid in weight loss. The trial will compare the effects of probiotics to a placebo, a pill with no active ingredients. Suitable participants have stable asthma, a body mass index over 30, and insulin resistance. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on probiotics and their potential benefits for asthma and metabolic health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your asthma medications have been stable for 3 months before joining. This suggests you should continue your current asthma medications without changes.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A previous study found that the probiotic Lactobacillus plantarum GKM3 helped balance gut bacteria in overweight or obese individuals. This change improved digestion and reduced fat intake. The study showed that participants tolerated the probiotic well, with no major side effects reported.

Other research has shown that probiotics can aid in weight management and improve overall gut health. This may benefit individuals with asthma and insulin resistance. Although the FDA has not yet approved this specific probiotic for these conditions, the results so far are promising for its safety and potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using probiotics for obese asthmatics with insulin resistance because these treatments offer a natural approach by introducing beneficial bacteria to the gut. Unlike standard treatments that often involve steroids or bronchodilators for asthma and medications like metformin for insulin resistance, probiotics aim to improve overall metabolic and immune health. This could potentially reduce inflammation and improve insulin sensitivity without the side effects commonly associated with conventional medications.

What evidence suggests that probiotics might be an effective treatment for obese asthmatics with insulin resistance?

Research has shown that probiotics might help with asthma and insulin resistance in people who are obese. In this trial, participants will receive either a probiotic supplement or a placebo. One study found that probiotics increased the amount of helpful bacteria called Bifidobacterium in the airways, which was linked to a decrease in certain immune cells often elevated in asthma. Another study indicated that probiotics might aid in weight loss and improve insulin use in the body. These early findings suggest that probiotics could be promising for managing asthma and insulin resistance in obese patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Jessy S Deshane, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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

Other significant medical conditions based on discretion of PI

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

I was hospitalized for asthma within the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either a probiotic supplement or placebo daily for 12 weeks

12 weeks

2 visits (in-person) at baseline and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Probiotic

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

American Lung Association

Collaborator

Trials

32

Recruited

11,000+

Published Research Related to This Trial

In a study involving 87 adults with obesity tendencies, the probiotic Lactobacillus gasseri SBT2055 (LG2055) significantly reduced abdominal visceral fat by an average of 4.6% and subcutaneous fat by 3.3% over 12 weeks, indicating its potential effectiveness in combating obesity.

Participants consuming LG2055 also experienced significant reductions in body weight (1.4%), BMI (1.5%), and waist circumference (1.8%), while the control group showed no significant changes, highlighting the probiotic's role in improving metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation of abdominal adiposity by probiotics (Lactobacillus gasseri SBT2055) in adults with obese tendencies in a randomized controlled trial. Kadooka, Y., Sato, M., Imaizumi, K., et al.[2022]

Citations

1. withpower.com withpower.com/trial/probiotics-for-obese-asthmatics-with-insulin-resistance-54c13

Probiotics for Obese Asthmatics with Insulin Resistance 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7465252/

Probiotics for the Treatment of Overweight and Obesity in ... 48 obese children with insulin resistance; 24 probiotic ... effect of probiotic supplementation on the prevention of overweight and obesity have been conducted.

3. trial.medpath.com trial.medpath.com/clinical-trial/deb000f9b3601c48/nct05949255-probiotics-insulin-resistance-obese-asthmatics

Probiotics and Insulin Resistance in Obese Asthmatics 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10825962/

Obesity-related asthma and its relationship with microbiota A high BMI at age 8 was found to be associated with an increased risk of later asthma with allergic rhinitis, while being overweight/obese at age 20 was ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1756464619305900

Impact of probiotics and prebiotics targeting metabolic ... muciniphila for 4 weeks in the diet of obese and diabetic mice reversed high-fat diet-induced obesity, insulin resistance, and type 2 diabetes. Additionally ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405457725003237

Impact of probiotic Lactobacillus plantarum GKM3 on ... Our study suggests that the strain GKM3 modulates gut flora, leading to reduced fat absorption and improved gastrointestinal functions in overweight and obese ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12206879/

Gut–lung axis in asthma and obesity An intervention study using a low energy diet for weight reduction in 211 overweight or obese participants revealed significant alterations in ...

8. frontiersin.org frontiersin.org/journals/allergy/articles/10.3389/falgy.2025.1618466/full

Gut–lung axis in asthma and obesity: role of the ... - Frontiers An intervention study using a low energy diet for weight reduction in 211 overweight or obese participants revealed significant alterations in the gut ...