Exercised Induced AsthmaNCT02872675
The Effects of Prebiotics on Gut Bacterial Parameters, Immune Function & Exercise-Induced Airway Inflammation.
A study testing HOST-DM059 and Maltodextrin in people with Exercised Induced Asthma and Asthma, run by Nottingham Trent University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercised Induced Asthma, Asthma
- What is being tested?
- HOST-DM059 and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2017to 30 Apr 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.).
- Participants with asthma who do not obtain an additional prescription for a reliever inhaler to be stored securely at NTU if needed during visits. Additional prescriptions must be obtained before familiarisation/visit two. Participants will be reimbursed for the cost of additional reliever inhaler prescriptions.
- History of heart failure, pulmonary hypertension, embolism, or other pulmonary heart disease.
- History of recurrent chest infections.
- Smoker.
- Pregnant, planning pregnancy or lactating.
- Had an acute infection in the last four weeks, and/or major operation in the past four months.
- History of gastrointestinal drug reaction.
- Have taken antibiotics in the past 3 months.
- History or current evidence of gastrointestinal disease (e.g. chronic constipation, diarrhoea, irritable bowel syndrome, Chrohn's disease).
- Have recently taken part in other research projects. Participants will be asked to notify the chief investigator.
- Participants are, or believe that they are lactose intolerant.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Trent University
Nottingham, Nottinghamshire, NG11 8NS
About this study
Official title: The Effects of HOST-DM059 Prebiotic Supplementation on Gut Bacterial Metabolites, and Markers of Systemic Inflammation in Adults With and Without Hyperpnoea-Induced Bronchoconstriction: A Double-Blind, Placebo-Controlled, Crossover Trial.
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.
Read the detailed description
The current study will investigate the effects of prebiotic supplementation on airway inflammation/bronchoconstriction in adults diagnosed with Asthma/Exercise-Induced Bronchoconstriction (A/EIB). Previous research conducted in adults diagnosed with A/EIB has reported significant improvements in pulmonary function following three weeks of prebiotic supplementation. The significant improvements in pulmonary function were attributed to an attenuation of various markers of airway inflammation, potentially regulated by gut microbiota mediated improvements in systemic immune function.
Prebiotics are a type of non-digestible carbohydrate/dietary fibre that can only be digested by certain beneficial bacteria. During the fermentation of prebiotics, beneficial bacteria produce energy/metabolites that can be used to support a variety of human immune functions, such as reducing the level of airway inflammation that occurs following exposure to relevant triggers (e.g. exercise).
Imbalances and/or deficiencies in gut bacterial composition/metabolic activity have been identified in children/adults diagnosed asthma. However, the potential mechanisms behind prebiotic mediated improvements in the severity of asthma have yet to be investigated.
Participants with and without A/EIB will be allocated two separate nutritional supplements following a double-blind, placebo-controlled design. During the first phase of the nutritional intervention, participants will consume the first supplement (either prebiotic or placebo), for a total duration of four weeks. A two-week wash out period will then be completed before the remaining nutritional supplement is administered for an equal duration.
Analyses of key human/bacterial metabolite concentrations will be carried out alongside assessments of immune and pulmonary function, and intestinal permeability at baseline, and throughout all phases of the nutritional intervention. Current understandings of the role of the gut microbiota in the pathogenesis of A/EIB will be expanded through the investigation of novel pathophysiological mechanisms, helping to inform future therapeutic prospects for asthma.
- Conditions
- Exercised Induced Asthma, Asthma
- Being tested
- HOST-DM059, Maltodextrin
- 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
- Medical subject headings
- Asthma, Exercise-Induced, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOST-DM059Dietary supplement
Also called Bimuno, B-GOS, Prebiotic, Galactooligosaccharide.
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.
MaltodextrinDietary supplement
Also called Placebo
Placebo Comparator: Maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: HOST-DM059 |
| Maltodextrin | Placebo comparator | Maltodextrin will be administered as a taste/appearance-matched sugar/carbohydrate. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (
Measured: Week 0, Week 4, Week 6, Week 10 (Collected At Rest).
Secondary outcomes (7)
Change In Systemic Immune Function/Inflammatory Markers
Flow Cytometric Analysis: Interleukin (IL)-10, Hematopoietic Prostaglandin D Synthase Enzyme (Pathogenic Effector/Non-Pathogenic Effector TH2 Cells), CD3 (T Cells), CD25 (Regulatory T Cells), Transforming Growth Factor-Beta (TH2 Cells), Fork-Head Box Protein-3 (Regulatory T Cells), CD161 (PETH2 Cells), Interferon-Gamma (TH1 Cells), Live/Dead, Total \& Specific White Blood Cell Counts (Eosinophils, Basophils, Neutrophils, Monocytes, Lymphocytes).
Measured: Week 0, Week 4, Week 6, Week 10 (Blood Sample Collected At Rest).
Change In Pulmonary Function (FEV1)
% Drop In Pulmonary Function (FEV1) Post EVH = 100*(Highest Baseline FEV1-Lowest Post EVH FEV1)/Highest Baseline FEV1. Used To Objectively Diagnose Asthma/EIB (> 10% Drop In FEV1 Post EVH At Two Consecutive Time Points), And Classify Severity As Mild (> 10% - < 25% Drop In FEV1), Moderate (> 25% - < 50% Drop In FEV1), Or Severe (> 30%, Or 50% Drop In FEV1 For Patients Receiving/Not Receiving Steroid Based Treatments).
All Pulmonary Function Parameters: FEV1, FVC, PEF, FEF25%-75%.
> 10% Reduction = Positive Objective Diagnosis (Asthma/EIB).
Measured: 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
Common Asthma Symptoms Management: Night Time Awakening, Upon Waking Symptom Severity, Physical Activity Limitation, Dyspnoea (Breathlessness), Wheezing, Reliever Medication Usage (Rating 0-6).
Measured: 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
E.G.: Acetic Acid, Propionic Acid, I-Butyric Acid, N-Butyric Acid, I-Valeric Acid, N-Valeric Acid, N-Caproic Acid.
Measured: 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)
Asthma Medication \& Nutritional Interventions Adherence Measurement (12 Questions) (Rating 1-5).
Measured: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. (Upon Experimental Trial Arrival During Weeks 0, 4, 6, & 10).
Change In 24 Hour Weighed Nutritional Intake Record
Quantitative Measurement - Habitual Nutritional Consumption (Assess Nutritional Intake Consistency Across Experimental Trials).
Measured: Week 0, Week 4, Week 8, Week 12 (24 Hours Before Experimental Trial).
Changes In Intestinal Permeability Markers
Blood (Serum/Plasma) Based Measurement.
Measured: Week 0, Week 4, Week 6, Week 10 (Blood Sample Collected At Rest).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start15 Nov 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Exercised Induced AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading, Clasado Biosciences, Imperial College London, HOST Therabiomics, The John van Geest Cancer Research Centre
- Responsible party
- Principal investigator, Paul Lester, Nottingham Trent University
- Investigators
- Graham R Sharpe, PhD, Study director, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872675
- Sponsor's protocol ID
- 233556
- Status last verified
- Sep 2020
- First submitted
- 4 Aug 2016
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may be made available to other researchers following completion of the current trial in an anonymised/pseudonymised format to prevent individual participant identification. Data will be provided in response to certain requests (e.g. if a systematic review and meta-analysis/statistical power calculation is being conducted that requires access to certain raw data).
Publications
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.
PubMed 26303339Vulevic 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.
PubMed 26218845Williams 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.
PubMed 27523186Hevia 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.
PubMed 26840903Arrieta 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.
PubMed 26424567
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of HOST-DM059 Prebiotic Supplementation on Gut Bacterial Metabolites, and Markers of Systemic Inflammation in Adults With and Without Hyperpnoea-Induced Bronchoconstriction: A Double-Blind, Placebo-Controlled, Crossover Trial.
- ClinicalTrials.gov ID
- NCT02872675
- Acronym / sponsor ID
- 233556
- Conditions
- Exercised Induced Asthma, Asthma
- Keywords
- Asthma, Exercise-Induced Asthma, Gut Bacteria, Bimuno® Galactooligosaccharide, Pulmonary Function, Prebiotics, Exercise-Induced Bronchoconstriction, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- University of Reading, Clasado Biosciences, Imperial College London, HOST Therabiomics, The John van Geest Cancer Research Centre
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current study will investigate the effects of prebiotic supplementation on airway inflammation/bronchoconstriction in adults diagnosed with Asthma/Exercise-Induced Bronchoconstriction (A/EIB). Previous research conducted in adults diagnosed with A/EIB has reported significant improvements in pulmonary function following three weeks of prebiotic supplementation. The significant improvements in pulmonary function were attributed to an attenuation of various markers of airway inflammation, potentially regulated by gut microbiota mediated improvements in systemic immune function.
Prebiotics are a type of non-digestible carbohydrate/dietary fibre that can only be digested by certain beneficial bacteria. During the fermentation of prebiotics, beneficial bacteria produce energy/metabolites that can be used to support a variety of human immune functions, such as reducing the level of airway inflammation that occurs following exposure to relevant triggers (e.g. exercise).
Imbalances and/or deficiencies in gut bacterial composition/metabolic activity have been identified in children/adults diagnosed asthma. However, the potential mechanisms behind prebiotic mediated improvements in the severity of asthma have yet to be investigated.
Participants with and without A/EIB will be allocated two separate nutritional supplements following a double-blind, placebo-controlled design. During the first phase of the nutritional intervention, participants will consume the first supplement (either prebiotic or placebo), for a total duration of four weeks. A two-week wash out period will then be completed before the remaining nutritional supplement is administered for an equal duration.
Analyses of key human/bacterial metabolite concentrations will be carried out alongside assessments of immune and pulmonary function, and intestinal permeability at baseline, and throughout all phases of the nutritional intervention. Current understandings of the role of the gut microbiota in the pathogenesis of A/EIB will be expanded through the investigation of novel pathophysiological mechanisms, helping to inform future therapeutic prospects for asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| HOST-DM059 (Prebiotic) | Experimental | Dietary Supplement: HOST-DM059HOST-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. |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin will be administered as a taste/appearance-matched sugar/carbohydrate. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (26 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOST-DM059Also: Bimuno, B-GOS, Prebiotic, Galactooligosaccharide.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. | Dietary supplement | HOST-DM059 (Prebiotic) |
| MaltodextrinAlso: PlaceboPlacebo Comparator: Maltodextrin. | Dietary supplement | Maltodextrin |
Primary outcome
Changes In Regulatory T Cell FOXP3 Expression From Baseline To Post Prebiotic Supplementation.
Time frame: Week 0, Week 4, Week 6, Week 10 (Collected At Rest).
Flow Cytometric Analysis: CD4+ CD25+ IL-10+ Regulatory T Cell FOXP3 Expression (
7 secondary outcomes
Change In Systemic Immune Function/Inflammatory Markers
Time frame: Week 0, Week 4, Week 6, Week 10 (Blood Sample Collected At Rest).
Change In Pulmonary Function (FEV1)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. (Upon Experimental Trial Arrival During Weeks 0, 4, 6, & 10).
Change In 24 Hour Weighed Nutritional Intake Record
Time frame: Week 0, Week 4, Week 8, Week 12 (24 Hours Before Experimental Trial).
Changes In Intestinal Permeability Markers
Time frame: Week 0, Week 4, Week 6, Week 10 (Blood Sample Collected At Rest).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 26303339Williams 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.
- Background: PubMed 26218845Vulevic 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.
- Background: PubMed 27523186Williams 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.
- Background: PubMed 26840903Hevia 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.
- Background: PubMed 26424567Arrieta 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.
- Individual participant dataSharing planned: Undecided. Individual participant data may be made available to other researchers following completion of the current trial in an anonymised/pseudonymised format to prevent individual participant identification. Data will be provided in response to certain requests (e.g. if a systematic review and meta-analysis/statistical power calculation is being conducted that requires access to certain raw data).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham R Sharpe, PhD study director
Nottingham Trent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOST-DM059 and Maltodextrin in people with Exercised Induced Asthma and Asthma, run by Nottingham Trent University at 1 site in United Kingdom.
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 7 inclusion and 26 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 9 Sep 2020. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Changes In Regulatory T Cell FOXP3 Expression From Baseline To Post Prebiotic Supplementation. (time frame: Week 0, Week 4, Week 6, Week 10 (Collected At Rest).). 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 NCT02872675, which also lists 5 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 9 Sep 2020.