NCT06361719招募中不适用
Efficacy of a Ready to Feed (RTF) Starter Liquid Infant Formula Containing 2'FL and LNnT in Chinese Infants: A Double-blind, Randomized Controlled Trial Including a Breastfed Reference Group
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2024年7月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Bifidobacteria abundance in fecal samples
研究概览
简要总结
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group.
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
- 3 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female infants of post-natal age of 3-14 days (date of birth = day 0), inclusive, at enrolment
- •Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the trial.
- •Infants whose parent(s) have reached the legal age of majority in China.
- •Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the trial protocol.
- •Infants whose parent(s)/LAR can be contacted directly by telephone throughout the trial.
- •Infants whose parent(s)/LAR have a working freezer.
- •Singleton, healthy, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
- •For the formula-fed groups: infant is exclusively consuming and tolerating a cow' s milk infant formula for at least 3 days prior to enrolment. The infant's mother has independently elected not to breastfeed.
- •For the breastfed reference group: infant has been exclusively consuming breastmilk since birth (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established) and the infant's mother has made the decision to continue exclusively breastfeeding until at least 3 months of age.
排除标准
- •Infants with conditions requiring infant feedings other than those specified in the protocol.
- •Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrolment.
- •Infants who have a medical condition or history that could increase the risk associated with trial participation or interfere with the interpretation of trial results, including: Evidence of major congenital malformations (e.g., cleft palate, extremity malformation). Documented or suspected systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis). Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the trial.
- •Infants who are presently receiving or have received prior to enrolment probiotic supplements or any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics and microbiota (e.g., oral and systemic antibiotics, glycerine suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.
- •Currently participating or having participated in another clinical trial since birth.
- •Infant who has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy.
结局指标
主要结局
Bifidobacteria abundance in fecal samples
时间窗: just prior to 3 months of age
Bifidobacteria abundance using qPCR technology
次要结局
- Infant Illness(From enrollment until 12 months of age)
- Gut microbiota composition(From enrollment until 12 months of age)
- Fecal metabolism(From enrollment until 12 months of age)
- Fecal markers of intestinal immune health(From enrollment until 6 months of age)
- Stool patterns(From enrollment until 12 months of age)
- GI symptoms and behaviors(From enrollment until 6 months of age)
- Immune competence(From enrollment until 12 months of age)
- Infant sleep duration and night-time wakings per 24 hours(From enrollment until 6 months of age)
- Infant Health Related Quality of Life(From enrollment until 6 months of age)
- Physical Examination(At enrollment and at 12 months of age)
- Infant illness, infections and medication usage(From the time the informed consent form has been signed at enrollment infant age less than 3 days until 12 months of age)
- Medication use (type and duration)(From enrollment until 12 months of age)
- Growth(From enrollment until 12 months of age)
- Fecal markers of gut barrier function(From enrollment until 6 months of age)
- Fecal markers of inflammation(From enrollment until 6 months of age)
研究者
研究点 (1)
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