ISRCTN11358769招募中未知
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.
ottingham Trent University0 个研究点目标入组 14 人开始时间: 2019年4月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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’.
排除标准
- •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.
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