NCT06073652进行中（未招募）不适用
Safety and Efficacy of a Starter Infant Formula With Synbiotics: a Double-blind, Randomized, Controlled Trial
Société des Produits Nestlé (SPN)3 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年7月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Safety of experimental formula demonstrated by growth
研究概览
简要总结
This randomized, double-blind, controlled intervention trial aims to evaluate the safety and efficacy of a starter infant formula supplemented with an HMO blend and a probiotic, and will provide evidence on the safety and efficacy of the innovative prebiotic/ probiotic blend to support age-appropriate infant growth, a healthy gut microbiome, gastrointestinal (GI) tolerance and GI health, and immune development.
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)
盲法说明
There are two masked, randomized formula-fed intervention groups, Control Formula (CF) and experimental Formula (EF)
入排标准
- 年龄范围
- 14 Days 至 35 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Evidence of personally signed and dated informed consent document indicating that at least one of the infant's parent(s)/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
- •Infants whose parent(s)/LAR(s) have reached the legal age of majority in the countries where the study is conducted.
- •Able to temporarily store stool samples in a household freezer.
- •Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol.
- •Infants whose parent(s)/LAR(s) are able to be contacted directly by telephone throughout the study.
- •Infants must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •Healthy term infant (≥37 weeks of gestation).
- •At enrollment visit, post-natal age ≥14 to ≤35 days / 0.75 - 1 month (date of birth = day 0)
- •Birth weight ≥ 2500g and ≤ 4500g.
- •For formula-fed groups, infants must be exclusively consuming and tolerating a cow's milk infant formula at time of enrollment and their parent(s)/LAR(s) must have independently elected, before enrollment, not to breastfeed.
- •For the breastfed group, infants must have 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 their parent(s)/LAR(s) must have made the decision to continue exclusively breastfeeding until at least 4 months of age.
排除标准
- •Infants with conditions requiring infant feedings other than those specified in the protocol.
- •Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- •Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
- •Suspected or documented 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 study. Of note, children who are normally healthy but at the time of enrolment suffering from acute illness in a minor condition which are common in childhood and do not require some of the exclusionary medication mentioned below can be enrolled.
- •Infants who are presently receiving or have received prior to enrolment 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 microbiota and characteristics (e.g., oral, or systemic antibiotics, glycerin 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 interventional clinical trial since birth.
研究组 & 干预措施
Control formula group
Active Comparator
The Control Formula group will receive 1st age infant formula exclusively for the first six months.
干预措施: Control 1st age starter infant formula (Other)
Experimental formula group
Experimental
The Experimental Formula group will receive 1st age infant formula identical to Control formula, but supplemented with a HMO blend and a probiotic exclusively for the first six months.
干预措施: Experimental 1st age starter infant formula (Other)
结局指标
主要结局
Safety of experimental formula demonstrated by growth
时间窗: Baseline Visit 1 to 4 months of age Visit 5
Weight gain comparison between infants from experimental and control group
次要结局
- Head circumference (cm)(Baseline Visit 1 to 6 month of age Visit 6)
- Length (cm)(Baseline Visit 1 to 6 month of age Visit 6)
- Antibiotic and antipyretic use(Baseline Visit 1 to 6 month of age Phone visit 7)
- Fecal microbiome(Baseline Visit 1 to 6 month of age Visit 6)
- Fecal cytokine profile(Baseline Visit 1 to 6 month of age Visit 6)
- Fecal metabolic profile(Baseline Visit 1 to 6 month of age Visit 6)
- 3-day GI Symptom and Behavior Diary(Baseline Visit 1 to 6 month of age Visit 6)
- Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) Index questionnaire(Baseline Visit 1 to 6 month of age Visit 6)
- Weight (g)(Baseline Visit 1 to 6 month of age Visit 6)
- Respiration(Baseline Visit 1 to 6 month of age Visit 6)
- Body temperature(Baseline Visit 1 to 6 month of age Visit 6)
- Physical examination(Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5)
- Efficacy of experimental formula demonstrated by fecal sIgA concentration.(Baseline Visit 1 to 4 months of age Visit 5)
- Fecal markers of immune health and gut barrier function(Baseline Visit 1 to 6 month of age Visit 6)
- Blood markers of systemic immunity(Baseline Visit 1 to 4 months of age Visit 5)
- Heart rate(Baseline Visit 1 to 6 month of age Visit 6)
- Pediatric Immune System Index and Infant Illness Questionnaire(Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5)
研究者
研究点 (3)
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