A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Alpha diversity.
研究概览
简要总结
Randomized controlled trial of soluble fiber (Fruitafit Inulin). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (Fruitafit Inulin) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet.
详细描述
A Phase II randomized, controlled, clinical trial analyzing the impact of increasing fiber intake and the gut microbiome for children with asthma. If eligible, (determined by inclusions/exclusion criteria as well as fiber intake assess by ASA 24) participants will be put into a fiber (Fruitafit Inulin) or placebo (Maltodextrin) group. Each participant will fil out an Asthma Control Questionnaire (ACQ), collect a nasal wash, and have their blood drawn. Their study medication will be available for them to pick up after their first visit, and they will receive counseling from the Pharmacist on how to implement it into their diet. They will also be sent home with three stool sample kits to be mailed to Northern Arizona University for microbiome and metabolomic analysis. The first kit will be sent within 7 days of their first visit. The second kit will be sent within 14 days (+/- 1 day) of their first visit. The second study visit will occur 25 days (+5 days) after the first visit. All the procedures will be repeated again including taking the ASA 24 questionnaire. The participant will send their final kit within 7 days of completing their last visit. Total study time is approx 30 days. This study is minimal risk which includes risk of fecal contamination, discomfort from collecting specimens, discomfort with answering some of the survey questions, and the risks associated with receiving a blood draw. Participants are compensated for their time and receive a portion of their dietary results. There may not be a direct benefit to the participant, but by participating in this research they may help people in the future with asthma.
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)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between ages 6-17
- •Asthma diagnosis within the last 2 years
- •Fractional excretion of exhaled nitric oxide (FeNO) > 50 ppb OR a clinical history of environmental allergies as defined by a positive skin prick or positive specific immunoglobulin E (IgE) tests to aeroallergens
- •No emergency department visits in the past 1 month
- •Ability to consume a liquid drink of fiber or placebo
- •Ability to return for a 4-6 week follow-up visit
- •No special or unique diet
排除标准
- •Cystic fibrosis
- •Bronchiectasis
- •Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks
- •Baseline estimated daily fiber intake less than or equal to 16 grams as determined by the ASA 24
- •Sibling of a participant already enrolled in the study
研究组 & 干预措施
A Phase II Randomized Controlled Trial of Soluble Fiber for Asthma
Participants are asked to fill out a dietary recall questionnaire (ASA 24) to determine eligibility in the study. If eligible, a nasal wash and blood sample will be collected at the first visit. Study drug or placebo will be given to participant after their visit in a randomized double-blinded nature. The participant will also fil out an Asthma Control Questionnaire (ACQ) and be sent home with 3 stool kits for analysis. Participant will turn in one sample after first visit, the second in three weeks, and the last one after the second study visit. At this second study visit, procedures from the first study visit will be repeated.
干预措施: Inulin (Drug)
Fiber Consumption and the Gut Microbiome Composition in a Pediatric Asthma Cohort
Participants are asked to complete a dietary recall questionnaire (ASA 24) that evaluates dietary intake in the last 24 hours. Participants are also sent home with a stool kit and instructions to collect a fecal sample for microbiome analysis. The purpose of the study is to better understand the pathways that connect diet and asthma.
结局指标
主要结局
Alpha diversity.
时间窗: 6 weeks
A total of 84 participants is required to find significant difference of 54 units of Richness at 90% power with a small effect size. Alpha diversity is used to measure the abundance that individual microbes can be observed. Statistical analysis is used to generate the significance of stool sample diversity as well as how many participants are needed to see the marker.
次要结局
- Asthma control.(6 weeks)
- Gut microbiome composition.(6 weeks)
- Nasal inflammatory response.(6 weeks)
- Quantification of circulating short chain fatty acids.(6 weeks)