The Gut Microbiota in the Pathophysiology of Exercise-Induced Asthma 1
Research type
Research Study
Full title
The Effects of HOST-DM059 Prebiotic Supplementation on Gut Bacterial Composition, Key Bacterial Metabolites, and Markers of Systemic Inflammation in Adults with and without Hyperpnoea-Induced Bronchoconstriction: A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial. For clarity, throughout this application ‘Hyperpnoea-Induced Bronchoconstriction’ is referred to as Asthma/Exercise-Induced Bronchoconstriction (A/EIB), to avoid potential confusion with the use of scientific terminology that may be misinterpreted by lay reviewers.
IRAS ID
200618
Contact name
Paul/PAL Lester
Contact email
Sponsor organisation
Nottingham Trent University
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Brief Title
The Effects of Prebiotics on Gut Bacterial Parameters, Immune Function & Asthma/Exercise-Induced Bronchoconstriction.
Summary
Beneficial gut bacteria play a vital role in immune function throughout life. Deficiencies in gut bacterial composition have been proposed as a central mediator of A/EIB. Deficiencies in gut bacterial composition have been observed in children at risk of asthma development, and adults with long-term allergic asthma, indicating that impairments could important contributing factors in A/EIB development. Dietary fibre intake has a substantial impact on gut bacterial composition, and subsequent immune function. As a result, nutritional therapies such as prebiotics have been explored. Research has demonstrated significant reductions in the severity of airway inflammation/bronchoconstriction following prebiotic supplementation. Prebiotics non-digestible carbohydrates/dietary fibre that selectively stimulate the growth and/or development of beneficial bacteria with prominent immunomodulatory/anti-inflammatory properties.
Exploring how positively altering gut bacterial composition through prebiotic supplementation contributes to reductions in the severity of A/EIB require further investigation. Novel evidence from these investigations could expand current understandings of A/EIB, and inform future treatment prospects. The current study will investigate the relationships between the gut bacteria and immune system in A/EIB, exploring how prebiotic supplementation contributes to improvements in pulmonary function.
Participants aged 18-50, male or female, who meet relevant inclusion/exclusion criteria, will attend Nottingham Trent University on six occasions over 14-weeks, for 10-12 hours in total. Visit one will be an initial consultation, visit two will be a familiarisation, and visits 3-6 will consist of main experimental trials. The procedures for objectively diagnosing A/EIB, and collecting blood, stool (bacterial/faecal), and urine samples will be explained, as well as how to complete a range of questionnaires/scales, and documentation of adverse events/serious adverse events. If participants do not wish to provide stool samples during their visits, they will be provided with the relevant equipment and instructions for the provision of samples at home (See Project Documents, ‘Home Stool Sample Collection Guidelines – 1.0’). The nutritional intervening being administered will be explained.
Funding has been provided by the Sport Science Department at NTU, collaborators from the University of Reading/Imperial College London with regards to bacterial/urine sample analysis, and Clasado Biosciences/Host Therabiomics with regards to nutritional supplements, and bacterial analysis being conducted at The University of Liverpool.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0245
Date of REC Opinion
1 Aug 2017
REC opinion
Unfavourable Opinion