The effects on asthma of dietary supplements that induce the growth or activity of beneficial microorganisms.

ISRCTN	ISRCTN11358769
DOI	https://doi.org/10.1186/ISRCTN11358769
IRAS number	253339
Secondary identifying numbers	IRAS Application: 253339

Submission date: 27/03/2019
Registration date: 04/04/2019
Last edited: 05/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Asthma is an inflammatory disorder that causes the narrowing of airways, increased production of mucus and therefore difficulty breathing. Asthma sufferers may experience shortness of breath, wheezing, tightness of the chest and a dry irritating cough. Asthma is a common condition that affects approximately 300 million people worldwide, in the UK 5.4 million people are currently recieving treatment. The NHS spend up to £1 billion a year for the care and treatment of those who have asthma.

This study will investigate how prebiotic supplementation affects asthma, by observing changes in quality of life, use of current medication and inflammation. Prebiotics are a carbohydrate that feed the ‘good bacteria’ in the gut, otherwise known as Probiotics. These bacteria have an important role in look after our immune system and a reduced number/activity of these ‘good bacteria’ may lead to development of asthma or increased severity of asthma. This study aims to increase our understanding of how the gut bacteria may affect asthma and the results may lead to a better understanding of the factors that might influence asthma and how these can be managed by targeting the diet.

Who can participate?
Adults diagnosed with asthma

What does the study involve?
Participants are randomly allocated into one of two groups. Group one are given a prebiotc supplement, known as B-GOS. Group two are given a placebo (dummy pill). Both groups will take the supplement, B-GOS, or placebo for 3 weeks. After this time, participants will continue as normal for two weeks, followed by another 3 weeks with either the placebo or B-GOS. Each participant will attend the laboratory for a lung function test, blood sample and to fill out questionnare before the start of each treatment; a total of 4 times over 8 weeks.

What are the possible benefits and risks of participating?
Participants may benefit from gaining a wider understanding into managing and controlling their asthma. Potential risks include possible discomfort when taking blood samples.

Where is the study located?
Nottingham Trent University, Clifton Campus (UK)

When does the study start and end?
June 2019 to June 2020

Who is the main contact.
Mr. Jacob Jayaratnasingam
Jacob.Jayaratnasingam2014@my.ntu.ac.uk

Contact information

Mr Jacob Jayaratnasingam
Scientific

Nottingham Trent University
Clifton Campus
Clifton Lane
Clifton
Nottingham
NG11 8NS
United Kingdom

ORCID ID	0000-0002-6497-5531
Phone	+44 (0)115 941 8418
Email	jacob.jayaratnasingam2014@my.ntu.ac.uk

Study information

Study design	Single centre double-blind placebo-controlled intervention crossover trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Home
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	The effects of Prebiotic Supplementation on Quality of Life, Control of Asthma, and Markers of Systemic Inflammation in Adults with Asthma. A Double-Blind, Placebo-Controlled, Crossover Trial.
Study acronym	PSA
Study objectives	Prebiotic supplementation will lead to significant changes in pro-inflammatory/anti-inflammatory markers in the blood.
Ethics approval(s)	Approval pending, East Midlands - Nottingham 1 Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; 0207 104 8104; NRESCommittee.EastMidlands-Nottingham1@nhs.net), ref: 19/EM/0088
Health condition(s) or problem(s) studied	Asthma, steps 1-4 according to the Birtish Thoracic Society Guidelines (BTS)
Intervention	Block randomisation will be used to randomise subjects into equal groups. At baseline, both groups will give a blood sample, undergo lung function tests, complete a 4-day food diary and asthma related questionnaires. The same measurements will be completed following prebiotic or placebo supplementation after 3-weeks. The measurements will then be completed again following a 2-week washout period. Groups will then crossover research arms and continue a 3 week supplementation period with either the prebiotic or placebo, before the final measurement. Supplements will be randomised by an independent party into 'X' and 'Y', ensuring the study is double blind. Blood samples will be analysed using flow cytometry and mass spectrometry to observe specific and general changes in protein expression.
Intervention type	Supplement
Primary outcome measure	Changes in FOXP3 expression by regulatory T cells in adults with asthma, following a prebiotic intervention crossover trial. Measured using flow cytometry at 4 timepoints as aforementioned, baseline, prebiotic, washout and placebo.
Secondary outcome measures	1. Changes in asthma control, and frequency of reliever medication in adults with asthma following prebiotic supplementation. Measured at 4 time points, baseline, prebiotic, washout and placebo; using the Asthma Control Questionnaire. 2. Changes in perception of asthma control (e.g. reduced frequency/severity of symptoms) following prebiotic supplementation. Measured at 4 time points, baseline, prebiotic, washout and placebo; using the Asthma Control Test. 3. Changes in quality of life following prebiotic supplementation. Measured at 4 time points, baseline, prebiotic, washout and placebo; using the Asthma Quality of Life Questionnaire
Overall study start date	22/08/2018
Completion date	24/06/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	Both
Target number of participants	14
Key inclusion criteria	1.18-50 years of age at the date of your first visit. 2. Body mass index (BMI) of 18.5-25 kg∙m2 (we can work this out for you using your height and body weight). 3. Non-smoker. 4. Asthma is defined as Steps 1 to 4 based on British Thoracic Society guidelines. 5. On a stable asthma treatment for 3 months 6. Current medication prescription from your GP if diagnosed with asthma (e.g. maintenance and reliever inhalers). 7. Be able and willing to follow all trial requirements. 8. Disclose any nutritional supplements you take to the researcher, to determine whether these may be considered as ‘exclusion criteria’.
Key exclusion criteria	1. Suffer from asthma but do not have a current medication prescription from your GP (e.g. maintenance and reliever inhalers). 2. Regularly consume Omega-3 supplements, and/or eat high levels of Omega-3 (e.g. more than 1-2 portions of oily fish such as salmon or mackerel a week). 3. Take aspirin or other non-steroidal anti-inflammatory drugs such as ibuprofen once a day on 5 of of the 7 days of the week. 4. Pregnant or planning a pregnancy during the time of the study (on each visit you will be asked to complete a pregnancy test if you are within childbearing age). 5. Consumed prebiotics and/or probiotics (supplements), drugs that affect gastrointestinal mobility or laxatives in the 4 weeks before signing the consent form. 6. Daily dose of anti-histamine, which you could not temporarily avoid for 72 hours before each testing session without exacerbation of symptoms. 7. Vegetarian or vegan diet. 8. Previously diagnosed with chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis, or similar respiratory (breathing-related) illness. 9. Admitted to hospital during the past 12 months for your asthma. 10. History of heart failure, pulmonary hypertension, embolism, or other pulmonary heart disease. 11. History of recurrent chest infections. 12. Acute infection in the last four weeks, and/or major operation in the past four months. 13. History of gastrointestinal drug reaction. 14. Taken antibiotics in the past 3 months. 15. History or current evidence of gastrointestinal disease (e.g. chronic constipation, diarrhoea, irritable bowel syndrome, Chrohn’s disease). 16. Recently taken part in other research projects. Please notify the chief investigator. 17. Lactose intolerant. 18. Regularly take antioxidant supplements, such as beta-carotene, vitamin A, vitamin C, vitamin E, lutein and selenium. Standard multivitamin and mineral supplements are acceptable; however, If a single antioxidant supplement (e.g. Vitamin C), is more than the recommended daily DRV’s this must be checked with the chief investigator.
Date of first enrolment	24/06/2019
Date of final enrolment	24/06/2020

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Nottingham Trent University Clifton Campus

Nottingham Trent University Clifton Campus
Clifton Lane
Clifton
Nottingham
Nottingham
NG11 8NS
United Kingdom

Sponsor information

Nottingham Trent University
University/education

Clifton Campus
Clifton Lane
Clifton
Nottingham
NG118NS
England
United Kingdom

Phone	+44 (0)115 941 8418
Email	dianne.levey@ntu.ac.uk
"ROR"	https://ror.org/04xyxjd90

Funders

Funder type

University/education

Nottingham Trent University
Private sector organisation / Universities (academic only)

Alternative name(s): NTU
Location: United Kingdom

Results and Publications

Intention to publish date	01/06/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Following study completion, it is planned the results will be published in 2021 in a high-impact peer-reviewed journal
IPD sharing plan	The current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

05/04/2019: Internal review.
29/03/2019: Trial’s existence confirmed by IRB