Oral Probiotic Administration to Modulate the Airway Microbiome in Obese Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Obesity is a major health concern in the Deep South resulting in a growing number of
      metabolic disorders that strain the resources of our healthcare system. Obesity is recognized
      as a major risk factor for asthma. The Centers for Disease Control and Prevention (CDC) has
      stated "obesity is associated significantly with the development of asthma, worsening asthma
      symptoms, and poor asthma control. This leads to increased medication use and
      hospitalizations."

      Variations in the airway microbiome are correlated with the risk for development of asthma,
      and populations of different bacteria vary by phenotype amongst severe asthmatics .
      Proteobacteria are found in greater proportion in asthmatic subjects relative to healthy
      controls (37% vs 15%) while non-asthmatic subjects have a relative abundance of Firmicutes
      (47% vs 63%) and Actinobacteria (10% vs 14%) compared to those with asthma . Amongst those
      with asthma, obese asthmatic subjects have a relative abundance of Bacteroides (54%) and
      Firmicutes (26%). Notably, both phyla are part of the gastrointestinal microbiome, suggesting
      inoculation through gastroesophageal reflux which may be more common in obese individuals.
      Asthmatics identified as having improvement in their asthma control following treatment with
      inhaled corticosteroids appear to have a greater relative abundance of Actinobacteria (79.8%)
      in their airways relative to other asthmatics. Actinobacteria have been associated with the
      production of anti-inflammatory proteins and are speculated to be involved in increasing
      steroid responsiveness. Other studies have demonstrated that oral administration of
      probiotics, including Bifidobacterium species within the phyla Actinobacteria, lead to
      reduced Th2 cytokine production and eosinophilic inflammation, along with promotion of
      Regulatory T-cell (Treg) populations within the airway. We hypothesize that administration of
      over the counter oral probiotics containing Actinobacteria (Bifidobacterium) to obese
      asthmatic subjects will result in decreased airway inflammation and better asthma control by
      immune modulation.
    


Intervention name(s): Seeking Health Probiota Bifido
Intervention type(s): Dietary Supplement
Intervention description(s): • This is a proof of concept study to demonstrate that oral probiotic use can modulate the airway microbiome. After informed consent has been obtained, this study will consist of 2 visits over a four week time period. Each visit will include a blood draw (30ml) and a research bronchoscopy/ bronchoalveolar lavage (BAL) (200ml) visit . A urine pregnancy test will be done on all females of childbearing potential prior to the first BAL as well as a CBC, BMP, and blood clotting tests in all participants. Following the first BAL, subjects will be asked to take an over the counter probiotic supplement (Seeking Health Probiota Bifido) nightly which will be provided to the participant by the study coordinator until the 2nd BAL is performed 4 weeks after the first BAL.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Asthma; obesity; micorbiome; probiotics