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The effect of prebiotic supplementation on asthma

The effects of a prebiotic supplement on quality of life, control of asthma, and markers of systemic inflammation in adults with asthma: a double-blind, placebo-controlled, crossover trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14120894
Enrollment
15
Registered
2021-05-19
Start date
2021-11-01
Completion date
Unknown
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Respiratory Asthma

Interventions

Participants are randomized by block randomisation for two 21-day treatment periods with a 2-week washout between treatments: 1. Prebiotic Bimuno galactooligosaccharide powder – 5.8 g

Sponsors

Nottingham Trent University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-50 years of age 2. Body mass index (BMI) of 18.5-35 kg·m² 3. Non-smoker 4. Asthma severity defined as Steps 1 to 5 based on British Thoracic Society guidelines 5. Current asthma diagnosis and medication prescription from GP (e.g. maintenance and reliever inhalers) 6. In the researcher’s opinion, able and willing to follow all the trial requirements 7. Potential participants must disclose any nutritional supplements they take to the researcher, to determine whether these may be considered as exclusion criteria

Exclusion criteria

Exclusion criteria: 1. Suffer from asthma but do not have a current medication prescription from 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 the 7 days of the week 4. Females only: pregnant or planning a pregnancy during the time of the study (on each visit participants will be asked to complete a pregnancy test if 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. Vegetarian or vegan diet 7. Previously diagnosed with chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis, or similar respiratory (breathing-related) illness 8. Admitted to hospital during the past 12 months for asthma 9. History of heart failure, pulmonary hypertension, embolism, or other pulmonary heart disease 10. History of recurrent chest infections 11. Acute infection in the last 4 weeks and/or major operation in the past 4 months 12. History of gastrointestinal drug reaction 13. Taken antibiotics in the past 3 months 14. History or current evidence of gastrointestinal disease (e.g. chronic constipation, diarrhoea, irritable bowel syndrome, Crohn’s disease) 15. Recently taken part in other research projects. Please notify the chief investigator 16. Are or believe they may be lactose intolerant 17. Regularly take antioxidant supplements, such as beta-carotene, vitamin A, vitamin C, vitamin E, lutein and selenium 18. Standard multivitamin and mineral supplements are acceptable; however, If a single antioxidant supplement (e.g. Vitamin C) is more than the recommended daily Dietary Reference Values (DRVs) this must be checked with the chief investigator

Design outcomes

Primary

MeasureTime frame
Pro-inflammatory markers including c-reactive protein, Th2 cytokines, Th1/17 cytokines, NFkB and TNFa measured using enzyme-linked immunosorbent assay and multiplex bead array assays at day 0 and day 21

Secondary

MeasureTime frame
1. Asthma control measured using the asthma control questionnaire (ACQ) at day 0 and day 21 of each intervention period 2. Asthma individual quality of life measured using the asthma quality of life questionnaire (AQLQ) at day 0 and day 21 of each intervention period 3. Use of asthma medication during the study measured using medication adherence report scale - for asthma (MARS-A) at day 0 and day 21 of each intervention period 4. Body composition measured using dual X-ray absorptometry (iDXA) at day 0 and day 21 of each intervention period

Countries

United Kingdom

Contacts

Public ContactNeil Williams
neil.williams@ntu.ac.uk+44 (0)1158485535

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026