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临床试验/NCT03673618
NCT03673618已完成2 期

Soluble Corn Fiber Supplementation for Asthma

Phoenix Children's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Asthma symptoms

研究概览

简要总结

Studies of the importance of the human microbiome have demonstrated that microbial metabolites of fermentation of our dietary products (e.g. dietary fiber) have a multitude of health benefits. The investigators aim to determine whether supplementation of asthmatic children with soluble corn fiber alongside standard of care reduces airway inflammation driven by the gut microbial metabolites acetate, propionate, or butyrate (short chain fatty acids).

详细描述

Asthma is a complex inflammatory disease of the airways that is estimated to affect 300 million people worldwide. Incidence of asthma is steadily increasing in Western populations; an additional 100 million asthma diagnoses are anticipated by the year 2025. Asthma is a multifactorial disease affected by genetic and environmental factors. One major and potentially modifiable environmental factor is the Western diet. The Western diet influences the microbiome, which in turn, may influence inflammatory airway diseases via a gut microbiome-airway connection. The investigators hypothesize that prebiotic dietary fiber supplementation leads to increased circulating short chain fatty acid production and improvement in asthma disease activity. The investigators will recruit 20 children, ages 6-17 years old, with asthma from the Severe Asthma Clinic or General Pulmonary Clinic at Phoenix Children's Hospital. Participants will be randomly assigned (1:1) using a random number generator to ingest PROMOTIR soluble corn fiber (85% fiber, 12 g/day) in a fruit-flavored beverage or placebo (malodextrin in a similar fruit-flavored beverage) as previously described. Participants will be asked to consume the prebiotic soluble corn fiber (or placebo) for 4 weeks alongside their normal diet and normal asthma treatments. Blood will be collected pre- and post-fiber intervention to measure baseline and post-intervention circulating SCFAs. Stool samples and nasal wash will be collected for microbiome and immune analysis pre- and post- fiber consumption. Nasal washes will be collected pre- and post-fiber consumption to measure inflammatory patterns.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

A study pharmacist will provide soluble corn fiber or a placebo (malodextrin) in identical packets to be dispensed in identical fruit-flavored beverage

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of asthma
  • Fractional excretion of exhaled nitric oxide (FeNO) > 50 ppb OR a history of environmental allergies
  • No emergency department or hospital visits for asthma in the past 3 months
  • No systemic corticosteroids in the past 1 month
  • Ability to consume a liquid drink of SCF or placebo
  • Ability to return for a 4-6 week follow-up visit
  • No special or unique diet as determined by PI/CO-Is.

排除标准

  • Cystic fibrosis
  • Bronchiectasis
  • Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks.

研究组 & 干预措施

PROMOTIR soluble corn fiber

Experimental

Participants will ingest PROMOTIR soluble corn fiber (85% fiber, 12 g/day) in a fruit-flavored beverage for 4 weeks alongside their normal diet and normal asthma treatments.

干预措施: Soluble Corn Fiber (Drug)

Malodextrin

Placebo Comparator

Participants will ingest malodextrin in a fruit-flavored beverage for 4 weeks alongside their normal diet and normal asthma treatments.

干预措施: Soluble Corn Fiber (Drug)

结局指标

主要结局

Asthma symptoms

时间窗: 4 weeks

Asthma Control Questionnaire

次要结局

  • Alpha and beta diversity in participants' nasal microbiome(Before treatment period and after treatment for 4 weeks)
  • Change in nasal wash Th2 gene expression(Before treatment period and after treatment for 4 weeks)
  • Alpha and beta diversity in participants' stool microbiome(Before treatment period and after treatment for 4 weeks)
  • Change in Serum Short Chain Fatty Acids(Before treatment period and after treatment for 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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