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AsthmaNCT03157518

Oral Probiotic Administration to Modulate the Airway Microbiome in Obese Asthmatic Subjects

A study testing Seeking Health Probiota Bifido in people with Asthma, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Asthma
What is being tested?
Seeking Health Probiota Bifido
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
1 Jul 2017to 18 Jun 2018
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

  • Moderate to severe asthma requiring medium to high dose inhaled corticosteroids
  • Patients will be recruited through the UAB Asthma Clinic and using the UAB Asthma Clinic Database for the Biospecimen Repository
  • Patients must show spirometry with positive bronchodilator reversibility or have a positive Methacholine Challenge Test within 3 years of enrollment
  • Obesity as defined as BMI over 30
  • Self-reported or radiographic evidence of gastroesophageal reflux disease
  • Ability and willingness to provide informed consent

Who cannot join

  • Inability of the subject to provide informed consent
  • Inability of the subject to undergo bronchoscopy
  • Use of monoclonal antibody within three months prior to enrollment
  • Use of immunosuppressive medication
  • Use of oral corticosteroids or antibiotics 4 weeks prior to enrollment
  • Use of anticoagulants (warfarin/Coumadin and heparin products).
Show all 9Show fewer
  • Use of aspirin and/or other non-steroidal anti-inflammatory drugs or clopidogrel (Plavix) within 5 days of bronchoscopy.
  • Pregnancy
  • Diagnosis of HIV, active cancer, or liver disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UAB Lung Health Center

    Birmingham, Alabama, 35294

Other trials in United States

About this study

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.

Conditions
Asthma
Being tested
Seeking Health Probiota Bifido
Keywords
Asthma, obesity, micorbiome, probiotics
Medical subject headings
Asthma, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seeking Health Probiota BifidoDietary supplement

    • 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.
Study groups in NCT03157518
Study groupRoleWhat they receive
Treatment ArmExperimentalPatients enrolled will receive probiotic supplementation following the first bronchoscopy for four weeks. A second bronchoscopy will be performed following probiotic administration.
Receives: Dietary Supplement: Seeking Health Probiota Bifido

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A change in the relative abundance of bifidobacterium species found in the airway.

    The relative abundance of bacterial species in the airways of participants will be quantified from samples obtained during bronchoscopy and compared at baseline and after using oral probiotic supplements daily.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2017
  2. Study start1 Jul 2017
  3. Primary completion18 Jun 2018
  4. Study completion18 Jun 2018

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03157518
Sponsor's protocol ID
F170105003
Status last verified
Jun 2018
First submitted
15 May 2017
Last updated
20 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual data will not be shared with researchers not included on the approved IRB

Publications

  • Hilty M, Burke C, Pedro H, Cardenas P, Bush A, Bossley C, Davies J, Ervine A, Poulter L, Pachter L, Moffatt MF, Cookson WO. Disordered microbial communities in asthmatic airways. PLoS One. 2010 Jan 5;5(1):e8578. doi: 10.1371/journal.pone.0008578.

    PubMed 20052417

  • Huang YJ, Nariya S, Harris JM, Lynch SV, Choy DF, Arron JR, Boushey H. The airway microbiome in patients with severe asthma: Associations with disease features and severity. J Allergy Clin Immunol. 2015 Oct;136(4):874-84. doi: 10.1016/j.jaci.2015.05.044. Epub 2015 Jul 26.

    PubMed 26220531

  • Marri PR, Stern DA, Wright AL, Billheimer D, Martinez FD. Asthma-associated differences in microbial composition of induced sputum. J Allergy Clin Immunol. 2013 Feb;131(2):346-52.e1-3. doi: 10.1016/j.jaci.2012.11.013. Epub 2012 Dec 23.

    PubMed 23265859

  • Huang YJ, Nelson CE, Brodie EL, Desantis TZ, Baek MS, Liu J, Woyke T, Allgaier M, Bristow J, Wiener-Kronish JP, Sutherland ER, King TS, Icitovic N, Martin RJ, Calhoun WJ, Castro M, Denlinger LC, Dimango E, Kraft M, Peters SP, Wasserman SI, Wechsler ME, Boushey HA, Lynch SV; National Heart, Lung, and Blood Institute's Asthma Clinical Research Network. Airway microbiota and bronchial hyperresponsiveness in patients with suboptimally controlled asthma. J Allergy Clin Immunol. 2011 Feb;127(2):372-381.e1-3. doi: 10.1016/j.jaci.2010.10.048. Epub 2010 Dec 30.

    PubMed 21194740

  • Chang P, Friedenberg F. Obesity and GERD. Gastroenterol Clin North Am. 2014 Mar;43(1):161-73. doi: 10.1016/j.gtc.2013.11.009. Epub 2013 Dec 27.

    PubMed 24503366

  • MacSharry J, O'Mahony C, Shalaby KH, Sheil B, Karmouty-Quintana H, Shanahan F, Martin JG. Immunomodulatory effects of feeding with Bifidobacterium longum on allergen-induced lung inflammation in the mouse. Pulm Pharmacol Ther. 2012 Aug;25(4):325-34. doi: 10.1016/j.pupt.2012.05.011. Epub 2012 Jun 13.

    PubMed 22705947

Questions about this trial

What is this clinical trial studying?

A study testing Seeking Health Probiota Bifido in people with Asthma, 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 20 Jun 2018. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

A change in the relative abundance of bifidobacterium species found in the airway. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03157518, which also lists 6 linked publications.

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 20 Jun 2018.

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