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临床试验/ISRCTN14120894
ISRCTN14120894进行中(未招募)未知

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

ottingham Trent University0 个研究点目标入组 15 人开始时间: 2021年5月19日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
15

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. 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

排除标准

  • 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

研究者

发起方
ottingham Trent University

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