NCT06943469招募中不适用
Synbiotics in Partially Hydrolysed Formula for Improved skiN Barrier Function in Infants at Risk for Allergy (SPHINX Study)
Société des Produits Nestlé (SPN)42 个研究点 分布在 5 个国家目标入组 400 人开始时间: 2025年4月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 42
- 主要终点
- TransEpidermal Water Loss (TEWL) at 3 months
研究概览
简要总结
The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable
- •Infant gestational age ≥ 37 completed weeks
- •Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
- •Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment
- •Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.
- •At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
- •a. For the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of age.
- •or b. For the randomized formula-fed groups only: infant is exclusively or predominantly formula-fed in the 24 hours prior to enrollment, with formula feeding representing at least 75% of total daily feeds. The decision to introduce formula feeding was independently made by the parents before enrollment.
- •Parents/LAR must be able to provide evidence of parental authority and identity.
- •Infant's parent(s)/LAR must understand the informed consent form and other study documents and are willing and able to fulfill the requirements of the study protocol.
排除标准
- •Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.
- •Infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for metabolic diseases) or requiring tube feeding.
- •Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.
- •Infant is currently participating or has previously participated in another clinical trial prior to enrollment.
- •Infant's parents or LARs have not reached legal age of majority (18 years).
研究组 & 干预措施
Test formula
Experimental
Partially hydrolyzed formula with synbiotics
干预措施: Test formula (Other)
Control formula
Active Comparator
Intact protein formula without synbiotics
干预措施: Control formula (Other)
Reference arm
No Intervention
Breastfed arm (not applicable for France)
结局指标
主要结局
TransEpidermal Water Loss (TEWL) at 3 months
时间窗: At 3 months of age
TransEpidermal water loss will be measured using a validated non-invasive technique.
次要结局
- Safety assessment(From enrollment to 13 months of age)
- Cumulative incidence of Atopic Dermatitis(From enrollment to 12 months of age)
- TransEpidermal Water Loss(From enrollment to 12 months of age)
- Skin surface (stratum corneum) hydration(From enrollment to 12 months of age)
- Extent and severity of Atopic Dermatitis(From 3 months to 12 months of age)
- Cumulative use of topical steroids and calcineurin inhibitors(From enrollment to 12 months of age)
- Skin natural moisturizing factors(From enrollment to 12 months of age)
- Skin cytokines(From enrollment to 12 months of age)
- Skin stratum corneum lipids(From enrollment to 12 months of age)
- Skin microbiome(From enrollment to 12 months of age)
- Skin metabolites(From enrollment to 12 months of age)
- Immune proteomics(From enrollment to 6 months of age)
- Immune blood cell immunophenotyping(From enrollment to 6 months of age)
- Specific IgE antibodies(At 12 months of age)
- Fecal microbiome(From enrollment to 12 months of age)
- Fecal metabolites(From enrollment to 12 months of age)
- Fecal biomarkers of inflammation and immunity(From enrollment to 12 months of age)
- Physician-diagnosed allergic manifestations(From enrollment to 12 months of age)
- Gastrointestinal tolerance(At enrollment and 4 months of age)
- Weight(From enrollment to 12 months of age)
- Height(From enrollment to 12 months of age)
- Head circumference(From enrollment to 12 months of age)
研究者
研究点 (42)
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