The Effects of Prebiotics on Gut Bacterial Parameters, Immune Function & Exercise-Induced Airway Inflammation.

NCT02872675 | Completed

• 1 other identifier: 233556
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to explore the role of prebiotic supplementation in adults with and without Asthma/Exercise-Induced Bronchoconstriction (A/EIB). All participants will be asked to consume a prebiotic supplement, and a placebo, each for a total duration of four weeks, separated by a two-week wash out period. The investigators hypothesise that improvements in pulmonary function observed in adults with Asthma following prebiotic supplementation. We hypothesise that improvements in pulmonary function will be attributed, at least in part, to gut microbiota mediated improvements in human immune function.

Conditions

Exercised Induced Asthma; Asthma

Keywords

Asthma; Exercise-Induced Asthma; Gut Bacteria; Bimuno® Galactooligosaccharide; Pulmonary Function; Prebiotics; Exercise-Induced Bronchoconstriction; Gut Microbiota; Nutritional Intervention; Eucapnic Voluntary Hyperpnoea; Systemic Inflammation; Systemic Immune Function; Regulatory T Cells; TH1 Cells; TH2 Cells; Short-Chain Fatty Acids; Acetate; Propionate; Butyrate; Metabolomics; Airway Inflammation; Intestinal Permeability

Outcome Measures

Primary Outcomes (1)

• Changes In Regulatory T Cell FOXP3 Expression From Baseline To Post Prebiotic Supplementation.

  Flow Cytometric Analysis: CD4+ CD25+ IL-10+ Regulatory T Cell FOXP3 Expression (

  Week 0, Week 4, Week 6, Week 10 (Collected At Rest).

Secondary Outcomes (7)

• Change In Systemic Immune Function/Inflammatory Markers

  Week 0, Week 4, Week 6, Week 10 (Blood Sample Collected At Rest).

• Change In Pulmonary Function (FEV1)

  Week 0, Week 4, Week 6, Week 10 (At Rest & In Duplicate At 3, 6, 10, 15, 20, & 30 Minutes Post EVH).

• Change In The Asthma Control Questionnaire - Perceived Symptom Management

  Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. (Upon Experimental Trial Arrival During Weeks 0, 4, 6, & 10).

• Change In Urinary Metabolite Concentrations

  Week 0, Week 4, Week 6, Week 10 (Urine Sample) (Collected At Rest & 60 Minutes Post EVH).

• Change In The Medication Adherence Report Scale For Asthma (MARS-A)

  Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. (Upon Experimental Trial Arrival During Weeks 0, 4, 6, & 10).

Other Outcomes (2)

• Principal Component Analysis/Cluster Analysis - Primary/Secondary Outcome Measures

  Post Data Collection.

• Partial Least Squares Discriminant Analysis.

  Post Data Collection.

Study Arms (2)

HOST-DM059 (Prebiotic)

EXPERIMENTAL

HOST-DM059 is the only Second Generation Prebiotic, manufactured by Clasado Biosciences/HOST Therabiomics. HOST-DM059 consists of a specific type of carbohydrate/dietary fibre (GOS), and an enzyme extracted from species of Bifidobacteria (e.g. The β-Galacotosidase Enzyme, \& Bifidobacterium Bifidum). The enzyme from which HOST-DM059 is developed provides a highly selective source of energy for certain species of Bifidobacteria. HOST-DM059 encourages the growth and development of Bifidobacteria. Certain species of Bifidobacteria have been demonstrated to exert prominent immunomodulatory effects in terms of regulating systemic inflammation.

Dietary Supplement: HOST-DM059

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin will be administered as a taste/appearance-matched sugar/carbohydrate.

Dietary Supplement: Maltodextrin

Interventions

HOST-DM059 DIETARY_SUPPLEMENT

Experimental Supplement: HOST-DM059. Participants will be asked to orally consume one powdered sachet each day, at the same time in the morning, reconstituted in tea/coffee/fruit juice, or sprinkled over cereal etc. Whichever method of consumption is chosen, this must be kept consistent across both supplementation phases.

Also known as: Bimuno, B-GOS, Prebiotic, Galactooligosaccharide.

HOST-DM059 (Prebiotic)

Maltodextrin DIETARY_SUPPLEMENT

Placebo Comparator: Maltodextrin.

Also known as: Placebo

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be 18-50 years of age at the date of your first visit.
• Have a body mass index (BMI) of 18.5-25 kg∙m2 (this will be worked out by the researchers using the participant's height and body weight).
• Be physically active (completing 3 or more exercise sessions a week lasting at least 45 minutes each).
• Be a non-smoker.
• Asthma is defined as Steps 1, 2, or 3 based on British Thoracic Society guidelines.
• Asthma sufferers must have a current medication prescription from their GP (e.g. maintenance/reliever inhalers).
• In the researcher's opinion, the participant is able and willing to follow all trial requirements.

You may not qualify if:

• Asthma defined as Steps 4 or 5 based on British Thoracic Society guidelines.
• Asthma sufferers who do not have a current medication prescription from their GP (e.g. maintenance and reliever inhalers).
• Regular consumption of Omega-3 supplements, and/or high levels of Omega-3 intake from food (e.g. consuming more than 1-2 portions of oily fish such as salmon or mackerel a week).
• Regularly consume antioxidant supplements.
• Standard multivitamin and mineral supplements are acceptable, as long as the product label states the recommended Dietary Reference Values (DRV's).
• If a single antioxidant supplement (e.g. Vitamin C), exceeds the recommended daily DRV's this will be checked with the chief investigator.
• Take a daily dose of aspirin or other non-steroidal anti-inflammatory drugs such as ibuprofen.
• Have consumed prebiotics and/or probiotics, drugs that affect gastrointestinal mobility, or laxatives in the 4 weeks before participation.
• Currently taking a daily dose of anti-histamine, which could not be refrained from for 72 hours before each testing session.
• Unable to refrain from taking Asthma medication (e.g. maintenance and reliever inhalers) for a prescribed duration before each testing session (e.g. 8-96 hours).
• Vegetarian or vegan diet.
• Previously diagnosed with chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis, or similar respiratory illness.
• Participants with asthma that have ever been hospitalised due to asthma (e.g. intensive care unit).
• Participants with asthma that have received treatment with oral corticosteroids/been admitted to hospital during the past 12 months for their asthma.
• An increase/step-up in asthma medication during the study (e.g. moving from Step 1 to Step 2, Step 2 to Step 3 etc.).

Sponsors & Collaborators

• Nottingham Trent University: lead
• University of Reading: collaborator
• Clasado Biosciences: collaborator
• Imperial College London: collaborator
• HOST Therabiomics: collaborator
• The John van Geest Cancer Research Centre: collaborator

Study Sites (1)

Nottingham Trent University

Nottingham, Nottinghamshire, NG11 8NS, United Kingdom

Location

Related Publications (5)

• Williams NC, Johnson MA, Hunter KA, Sharpe GR. Reproducibility of the bronchoconstrictive response to eucapnic voluntary hyperpnoea. Respir Med. 2015 Oct;109(10):1262-7. doi: 10.1016/j.rmed.2015.08.006. Epub 2015 Aug 13.

  PMID: 26303339 BACKGROUND

• Vulevic J, Juric A, Walton GE, Claus SP, Tzortzis G, Toward RE, Gibson GR. Influence of galacto-oligosaccharide mixture (B-GOS) on gut microbiota, immune parameters and metabonomics in elderly persons. Br J Nutr. 2015 Aug 28;114(4):586-95. doi: 10.1017/S0007114515001889. Epub 2015 Jul 28.

  PMID: 26218845 BACKGROUND

• Williams NC, Johnson MA, Shaw DE, Spendlove I, Vulevic J, Sharpe GR, Hunter KA. A prebiotic galactooligosaccharide mixture reduces severity of hyperpnoea-induced bronchoconstriction and markers of airway inflammation. Br J Nutr. 2016 Sep;116(5):798-804. doi: 10.1017/S0007114516002762.

  PMID: 27523186 BACKGROUND

• Hevia A, Milani C, Lopez P, Donado CD, Cuervo A, Gonzalez S, Suarez A, Turroni F, Gueimonde M, Ventura M, Sanchez B, Margolles A. Allergic Patients with Long-Term Asthma Display Low Levels of Bifidobacterium adolescentis. PLoS One. 2016 Feb 3;11(2):e0147809. doi: 10.1371/journal.pone.0147809. eCollection 2016.

  PMID: 26840903 BACKGROUND

• Arrieta MC, Stiemsma LT, Dimitriu PA, Thorson L, Russell S, Yurist-Doutsch S, Kuzeljevic B, Gold MJ, Britton HM, Lefebvre DL, Subbarao P, Mandhane P, Becker A, McNagny KM, Sears MR, Kollmann T; CHILD Study Investigators; Mohn WW, Turvey SE, Finlay BB. Early infancy microbial and metabolic alterations affect risk of childhood asthma. Sci Transl Med. 2015 Sep 30;7(307):307ra152. doi: 10.1126/scitranslmed.aab2271.

  PMID: 26424567 BACKGROUND

MeSH Terms

Conditions

Asthma, Exercise-Induced; Asthma

Interventions

Prebiotics; maltodextrin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Graham R Sharpe, PhD

  Nottingham Trent University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the company providing the nutritional supplements (HOST Therabiomics) will be aware of the supplement blinding protocol. Upon trial completion (e.g. the final visit of the final participant), the chief investigator will contact HOST Therabiomics to obtain information on the supplement blinding protocol. Should any participants, care providers, investigators, or outcome assessors become aware of the blinding protocol during the trial they will be informed not to disclose this information to any other relevant personnel. Participants who become aware of the blinding protocol during participation would be withdrawn from the trial.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, Principal Investigator

Model Details: Participants will be administered a prebiotic (galactooligosaccharide; HOST-DM059), and a taste/appearance matched placebo (Maltodextrin) in a, double-blind, placebo-controlled, crossover design. The nutritional intervention will be completed over a twelve week period, consisting of two, four-week supplementation phases separated by a four-week wash out period. Participants will be randomly allocated one of the nutritional supplements during phase one (labelled as either 'L', or 'X'), and asked to consume one powdered sachet every morning (3.6g). Participants will then complete a four week wash out period, before being assigned the remaining nutritional supplement during phase two. Sachets can be reconstituted in tea/coffee/fruit juice, or sprinkled over cereal etc.

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 19, 2016
• Study Start: November 15, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

GB (1)