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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Probiotic, Beneficial bacteria, Live cultures, Microbial supplements for obese asthmatics with insulin resistance?

Research shows that probiotics can help reduce asthma symptoms by improving gut health and reducing inflammation. Studies in children and animal models suggest that probiotics may help manage asthma by balancing the immune system and gut bacteria. ^{1 2 3 4 5}

Are probiotics safe for humans?

Probiotics, which are live beneficial bacteria, are generally considered safe for humans and have been used in various conditions like allergies and asthma. However, it's important to note that the effectiveness and safety can vary depending on the specific type of probiotic and the condition being treated. ^{6 7 8 9 10}

How is the probiotic treatment different from other treatments for obese asthmatics with insulin resistance?

Probiotic treatment is unique because it uses beneficial bacteria to potentially improve gut health and immune response, which may help manage asthma symptoms and inflammation. Unlike traditional asthma treatments that focus on directly targeting the lungs, probiotics aim to restore balance in the gut microbiome, which can indirectly influence respiratory health. ^{2 3 7 9 11}

Research Team

Jessy S Deshane, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Other significant medical conditions based on discretion of PI

I was hospitalized for asthma within the last 3 months.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The use of probiotics as a supplementary therapy in the treatment of patients with asthma: a pilot study and implications. [2022]

2. Egypt pubmed.ncbi.nlm.nih.gov

The Probiotics in Pediatric Asthma Management (PROPAM) Study in the Primary Care Setting: A Randomized, Controlled, Double-Blind Trial with Ligilactobacillus salivarius LS01 (DSM 22775) and Bifidobacterium breve B632 (DSM 24706). [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of Diet on the Effect of the Probiotic Lactobacillus paracasei in Rats Suffering From Allergic Asthma. [2021]

4. Australia pubmed.ncbi.nlm.nih.gov

Probiotics supplementation in children with asthma: A systematic review and meta-analysis. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Exploration of the effect of mixed probiotics on microbiota of allergic asthma mice. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Regulation of abdominal adiposity by probiotics (Lactobacillus gasseri SBT2055) in adults with obese tendencies in a randomized controlled trial. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Probiotics in the atopic march: highlights and new insights. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

Probiotics and Prebiotics for Prevention of Food Allergy: Indications and Recommendations by Societies and Institutions. [2018]

9. China pubmed.ncbi.nlm.nih.gov

[Roles of Probiotic Supplementation in the Prevention and Treatment of Asthma:A Systematic Review]. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

A 10-patient case study on the influence of two different probiotics on individual intestinal microbiota. [2014]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Alpha-lipoic acid, apocynin or probiotics influence glutathione status and selected inflammatory parameters in C57/BL6 mice when combined with a low-fat diet. [2023]