Infant Formula Study With Pre- And Postbiotics
2026年8月26日 更新者：Nutricia UK Ltd
Gastrointestinal Tolerance, Safety And Acceptability In Infants Consuming Palm Oil Free Infant Formula Containing Prebiotics And Postbiotics
This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula containing prebiotics and postbiotics derived from fermentation over a 24-week period.
Infants aged 0 to 6 weeks who were exclusively formula-fed at enrolment received the study formula as their sole source of nutrition.
The primary objective is to assess gastrointestinal tolerance and safety.
Secondary objectives include assessment of infant quality of life, parental experience and to characterise the development of the infant gut microbiome.
The study includes four visits over 24 weeks, during which clinical measurements, safety assessments, and sample collection are performed.
研究概览
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Cork、爱尔兰
- Atlantia Food Clinical Trials
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
是的
描述
Inclusion criteria:
- Parent's or legal guardian's aged 18 years, written informed consent.
- Infants exclusively formula fed at enrolment and parents/legal guardians have autonomously decided to exclusively formula feed until the end of intervention.
- Infants aged 0 to 6 weeks (day 0 to day 42 inclusive).
- Healthy term singleton infants, gestational age ~ 37 and < 42 weeks (i.e.,~ 41 weeks+ 6 days). Healthy is defined as no supervision or medical treatment by a medical specialist.
- Birth weight between 2.5 - 4.5 kg (within normal range for gestational age and sex, according to WHO definitions).
- Willing to continue using the infant formula, during the study, not switching of formula, except for medical purposes in which case the infant would be excluded.
Exclusion criteria:
- Infants with congenital condition and/or previous or current illness and (or) medication use that could interfere with the study, in the opinion of the medical doctor.
- Infants with established or suspected cows' milk allergy, lactose intolerance, galactosaemia, or infants on a prescribed fibre-free (e.g., prebiotic oligosaccharides) diet.
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Investigator's uncertainty about the willingness or ability of the parents/legal guardians to comply with the protocol requirements.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Infant formula
24-weeks consumption of cow's milk based palm oil free infant formula with prebiotics and postbiotics derived from fermentation
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Cow's milk based infant formula with with prebiotics and postbiotics derived from fermentation
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Gastrointestinal Tolerance - Stool consistency and frequency
大体时间：24 weeks
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Gastrointestinal tolerance evaluated with stool consistency and stool frequency for 3 consecutive days after first intake of study product and before each visit at week 2, week 10, and week 24 of intervention.
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24 weeks
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Safety - Growth (Weight)
大体时间：24 weeks
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Safety parameters included weight gain measured at baseline, week 2, week 10, and week 24 of intervention.
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24 weeks
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Safety - Growth (Length)
大体时间：24 weeks
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Safety parameters included length gain measured at baseline, week 2, week 10, and week 24 of intervention.
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24 weeks
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Safety - Growth (Head circumference)
大体时间：24 weeks
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Safety parameters included head circumference measured at baseline, week 2, week 10, and week 24 of intervention.
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24 weeks
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Safety - Adverse Events
大体时间：24 weeks
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Occurrence of (serious) AE measured throughout the intervention period.
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24 weeks
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Gastrointestinal Tolerance - Pediatric Quality of Life Inventory (PedsQL)
大体时间：24 weeks
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Scores are transformed to a 0 to 100 scale, with higher scores indicating better health-related quality of life and fewer problems.
PedsQL to assess infant's quality of life at baseline and week 2, week 10, and week 24.
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24 weeks
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Gastrointestinal Tolerance - Infant Gastrointestinal Symptom Questionnaire (IGSQ-13)
大体时间：24 weeks
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The IGSQ-13 consists of 13 items with a total score ranging from 13 to 65, where lower scores indicate better gastrointestinal tolerance and fewer symptoms, and higher scores indicate greater gastrointestinal distress.
IGSQ-13 questionnaire to asses gastrointestinal tolerance at baseline and week 2, week 10, and week 24.
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24 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Exploratory parameter - Gut Microbiota
大体时间：24 weeks
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Characterisation of the gut microbiota composition and functionality of infants consuming the study product at baseline and week 2, week 10, and week 24 using metagenomics and culturomics sequencing methods.
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24 weeks
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Exploratory parameter - Parent's Product Acceptability
大体时间：24 weeks
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To assess acceptability of the study product at baseline and week 2, week 10, and week 24 using a product evaluation questionnaire.
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24 weeks
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Exploratory parameter - Comparison with INFANTMET study
大体时间：24 weeks
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Comparison of gut microbiota composition and functionality with an external reference cohort of exclusively breastfed infants from the INFANTMET study.
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24 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Catherine Stanton、Teagasc
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年6月17日
初级完成 (实际的)
2023年10月18日
研究完成 (实际的)
2023年10月18日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年7月23日
首次发布 (实际的)
2026年7月29日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.