NCT04662619已完成不适用
A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Nutritional Intervention Study to Examine the Clinical and Immunological Effects of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis
Johnson & Johnson Consumer Inc. (J&JCI)2 个研究点 分布在 1 个国家目标入组 273 人开始时间: 2020年12月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 273
- 试验地点
- 2
- 主要终点
- Percentage of Participants with Atopic Dermatitis (AD) through Week 52
研究概览
简要总结
The purpose of this study is to assess the effect of B. infantis (EVC001) versus placebo supplementation, in healthy breastfed infants at risk of developing atopic dermatitis (AD), on cumulative incidence of physician-diagnosed AD during the first year of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infant
- •Has at least one first degree relative (that is biological parent or full sibling) with a history of atopic disease (that is mother-reported, physician-diagnosed Atopic Dermatitis (AD), allergic rhinitis, or asthma)
- •Breastfeeding established (as determined by the principal Investigator [PI] or designee) at the time of study enrollment (Day 0), with maternal intent to maintain exclusive breastfeeding for greater than or equal to (>=)12 weeks
- •Will participate in the study under supervision of his/her biological mother ("Caregiver") who is: a) At least 18 years old b) The legal guardian of the infant c) Intending to cohabitate with the infant for the duration of the study d) Willing to follow all Caregiver responsibilities e) Fluent in Finnish, Swedish, or English
- •The PI considers the Caregiver likely to adequately comply with the study protocol requirements based on demonstrated compliance with antenatal appointments and agreement to complete the intuitive, interactive, electronic diary (eDiary) utilizing personal smart device (example, tablet, cell phone)
排除标准
- •Preterm delivery (< 36 weeks [252 days] gestational age)
- •Admission to the neonatal unit for issues other than establishment of normal feeding
- •Evidence of a baseline illness/condition (example abnormal birth weight) or significant risk of developing an illness/condition (based on review of maternal/pregnancy information) that would, in the opinion of the Principal Investigator (PI) or designee, introduce a significant safety concern if the infant were enrolled in the study or otherwise preclude study participation
- •Significant birth defect/complication that would, in the opinion of the PI or designee, create a safety concern or otherwise confound the study (example, abdominal wall defects, congenital heart disease)
- •Severe widespread skin condition (example collodion)
- •Has consumed greater than (>)100 milliliter (mL) of formula per day within the 48 hours prior to enrollment (Day 0)
- •Twin or multiple births
- •Atopic dermatitis (AD) diagnosed at Day 0
- •Has a history of confirmed coronavirus disease 2019 (COVID-19) within 30 days prior to any on-site visit
- •Within 14 days prior to Visit 1, has been in close contact (exposure within 6 feet for a cumulative time of 15 minutes or more over a 24-hour period) with anyone who has a confirmed case of COVID-19
- •Is under a COVID-19 isolation/quarantine order
- •Has had self-reported (for Caregiver) or parent-reported (for infant) symptoms of COVID-19 within 14 days prior to the screening visit, such as unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, or chest pain/tightness
研究组 & 干预措施
B. infantis
Experimental
A once-daily feeding of activated B. infantis EVC001 (8.0 *10^9 colony forming units [CFU]) will be provided to infants for 12 weeks.
干预措施: B. infantis (Other)
结局指标
主要结局
Percentage of Participants with Atopic Dermatitis (AD) through Week 52
时间窗: Up to Week 52
Percentage of participants with atopic dermatitis (AD) through Week 52 will be reported. AD will be diagnosed if three of the following four criteria are met: 1) pruritus, 2) typical morphology and distribution (facial and extensor involvement), 3) chronic or chronically relapsing dermatitis, 4) personal or family history of atopic disease.
次要结局
- Percentage of Infants with B. infantis Gut Colonization at Week 12(Week 12)
- Percentage of Participants with at least Mild Atopic Dermatitis (AD) Severity Based on the Eczema Area and Severity Index (EASI) Score at Weeks 12, 52, and 104(At Weeks 12, 52, and 104)
- Time to Onset of at least Mild Atopic Dermatitis (AD) Severity Based on the Eczema Area and Severity Index (EASI) Score(At the time of AD onset (up to Week 104))
- Percentage of Infants with Adverse Events Through Weeks 12, 52 and 104(Up to Weeks 12, 52 and 104)
- Percentage of Participants with Atopic Dermatitis (AD) Through Weeks 24 and 104(Up to Weeks 24 and 104)
- Time to Onset of AD Through Weeks 52 and 104(Up to Weeks 52 and 104)
- Percentage of Participants with at least Mild AD Severity Based on the Patient-Oriented Eczema Measure (POEM) Score at Weeks 12, 52, and 104(At Weeks 12, 52, and 104)
- Time to Onset of at least Mild AD Severity Based on the Patient-Oriented Eczema Measure (POEM) Score(At the time of AD onset (up to Week 104))
研究者
研究点 (2)
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