Fiber Supplementation In Children With Peanut Allergy On Oral Immunotherapy: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The Proportion of Subjects Mildly Symptomatic or Less at the 12 Month DBPCFC
研究概览
简要总结
The purpose of this research is to gather information on the safety and efficacy of using a prebiotic as an adjunctive therapy to peanut oral immunotherapy. The prebiotic is not an FDA approved drug or medication rather a fiber found at local grocery stores.
详细描述
By doing this study, we hope to learn if using a dietary fiber called a "prebiotic" helps increase the number of children who can tolerate eating 1043mg of peanut protein (or about 3-4 peanuts) after going through oral immunotherapy (OIT) to peanut. We are also trying to determine if this fiber will reduce the side effects of OIT and if so, we would like to find out if the reason it is working is by changing the bacteria in the gut. Participation in this research will last about five years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4 to 17 (inclusive)
- •A convincing clinical history of peanut allergy
- •Immune markers consistent with peanut allergy
- •Serum IgE to peanut of >0.35 kUA/L and a skin prick test to peanut >8mm greater than the negative saline control -or-
- •Serum IgE to peanut of >5 kUA/L and a mean peanut wheal diameter on skin prick test 3 to 8mm greater than the negative saline control -or-
- •Serum IgE to peanut of >14 kUA/L and mean peanut wheal diameter on skin prick test 3mm greater than the negative saline control
- •Experience dose-limiting symptoms at or before 100mg challenge dose of peanut protein on screening double blind placebo-controlled food challenge (DBPCFC)
- •Written informed consent from parent/guardian
- •Written assent from subjects above the age of 7
排除标准
- •• History of a chronic disease (other than asthma, allergic rhinitis, and atopic dermatitis) that is at significant risk of becoming unstable or requiring a change in chronic therapeutic regimen
- •History of mast cell disease
- •History of recurrent idiopathic or virally induced urticaria, angioedema or anaphylaxis
- •Any history or presence of autoimmune, cardiovascular disease, chronic lung disease (other than asthma), malignancy, psychiatric illness, or gastrointestinal inflammatory conditions, including celiac disease, inflammatory bowel disease, eosinophilic esophagitis or other eosinophilic gastrointestinal disease
- •Current participation in any other interventional study
- •Subject who has undergone any type of oral immunotherapy
- •Severe asthma or uncontrolled mild to moderate asthma
- •Uncontrolled atopic dermatitis
- •Current use of oral steroid medications
- •Use of >1 bursts of oral steroid medications in the past year
- •Inability to eat by mouth the fiber supplementation or placebo control and peanut flour for any reason
- •Use of any therapeutic antibody (biologic medication) or any immunomodulatory medication in the past 12 month (other than a short course of oral steroids)
- •Current use of any type of immunotherapy
- •Pregnancy or lactation
- •Allergy to potato or corn oat or cow's milk
- •Unwillingness to carry an epinephrine auto-injector
- •Unwillingness to comply with activity restrictions during OIT or any other study procedure
研究组 & 干预措施
Treatment Group
Subjects who meet inclusion criteria will be randomized 1:1. The treatment group will receive prebiotic therapy for 30 days, then subjects will start peanut oral immunotherapy (POIT) in addition to the prebiotic. Subjects will continue through a prescribed course of POIT for approximately 180 days. After completion of POIT up-dosing, subjects will continue on maintenance POIT plus prebiotic therapy for an additional 180 days at which time they will undergo a DBPCFC. Subjects will then stop prebiotic therapy and continue on maintenance POIT in extended observation for approximately 4 years.
干预措施: Prebiotic (Drug)
Control Group
Subjects who meet inclusion criteria will be randomized 1:1. The control group will receive placebo therapy for 30 days, then subjects will start peanut oral immunotherapy (POIT) in addition to the placebo. Subjects will continue through a prescribed course of POIT for approximately 180 days. After completion of POIT up-dosing, subjects will continue on maintenance POIT plus placebo for an additional 180 days at which time they will undergo a DBPCFC. Subjects will then stop placebo and continue on maintenance POIT in extended observation for approximately 4 years.
干预措施: Placebo (Drug)
结局指标
主要结局
The Proportion of Subjects Mildly Symptomatic or Less at the 12 Month DBPCFC
时间窗: At the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
To determine the proportion of subjects who met the primary endpoint by tolerating at least 2044 mg cumulative peanut protein with no more than mild symptoms during the 12-month DBPCFC.
次要结局
- The Proportion of Subjects Who Experience Dose Related GI Side Effects During Oral Immunotherapy(From first study intervention through the final exit food challenge visit, up to 15 months.)
- The Proportion of Subjects Who Experience Hypersensitivity Reactions (Other Than GI) During Oral Immunotherapy(From first study intervention through the final exit food challenge visit, up to 15 months.)