Safety and Efficacy of Starter Infant Formula, Follow-up Formula and Growing-up Milk Supplemented With Pre- and Probiotic(s): a Double-blind, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 318
- 试验地点
- 33
- 主要终点
- Weight
研究概览
简要总结
This is a randomized, controlled, multicenter, double-blind study of healthy term infants. The primary objective of the trial is to demonstrate the safety of a a starter infant formula supplemented with pre- and probiotic(s) by comparing the growth of infants randomized to the experimental formula versus the control formula from enrolment to 4 months of age.
详细描述
This is a randomized, controlled, multicenter, double-blind study of healthy term infants, consisting of two randomized formula-fed arms (control and experimental formulas) and a non-randomized breast-fed reference group.
The population under investigation are healthy infants aged ≤14 days at enrollment. The planned sample size for formula-fed infants is 236 (118 per study group). A non-randomized breastfed reference group of 90 healthy, term, exclusively breastfed infants up to 4 months will also be enrolled.
Study formulas are administrated orally, ad libitum, from enrollment until 15 months of age.
The primary objective of the trial is to demonstrate the safety of a starter infant formula supplemented with pre- and probiotic(s) by comparing the growth (weight gain, g/day) of infants randomized to the experimental formula versus the control formula from enrolment to 4 months of age.
In addition fecal microbiome, fecal metabolic profile, fecal markers of immune and gut health, blood markers of immune health (in a subset of 60 infants/group), GI tolerance, bone index (subset of 40 infants/group), other anthropometric measurements, dietary pattern and infant illness and infection outcomes will be assessed/measured.
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
Unique coding of the study products
入排标准
- 年龄范围
- 0 Days 至 14 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 the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the study.
- •Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.
- •Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
- •Infants whose parent(s)/LAR 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 days/0.5 months
- •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 must have independently elected, before enrollment, not to breastfeed.
- •For the breastfed group, infants must have been exclusively consuming breast milk since birth, and their parent(s)/LAR 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 enrollment 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 enrollment 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 clinical trial since birth.
- •Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol
结局指标
主要结局
Weight
时间窗: From baseline (≤14 days) to 4 months of age
Weight gain measured as mean daily weight gain in g/day
次要结局
- Fecal metabolic profile: fecal organic acids(Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age)
- Fecal markers of immune health and gut barrier(Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age)
- Fecal cytokine profile(Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age)
- Bifidobacteria abundance(At 90 days (3 months of age))
- Fecal metabolic profile: fecal pH(Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age)
- GI-related behavior: stool consistency(Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age)
- Blood markers of immune health(At 4 months of age)
- GI-related behaviour: volume of formula consumed(Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age)
- Fecal microbiome(Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age)
- GI-related behavior: incidence of flatulence(Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age)
- GI-related behavior: crying time(Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age)
- GI-related behavior: sleep time(Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age)
- Infant Gastrointestinal Symptom Index(At baseline, 1, 2, 3, 4, 6, 9, 12 and 15 months of infant age)
- Bone index(At baseline, 3, 6, 9, 12 and 15 months of infant age)
- Additional growth parameters: length(At infant age ≤14 days (baseline), 1, 2, 3, 4, 6, 9, 12 and 15 months of age)
- Additional growth parameters:head circumference(At infant age ≤14 days (baseline), 1, 2, 3, 4, 6, 9, 12 and 15 months of age)
- Additional growth parameters: Body Mass Index(At infant age ≤14 days (baseline), 1, 2, 3, 4, 6, 9, 12 and 15 months of age)
- GI-related behavior: stool frequency(Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age)
- GI-related behavior: incidence of spitting(Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age)
- Additional growth parameters: weight(At infant age ≤14 days (baseline), 1, 2, 3, 4, 6, 9, 12 and 15 months of age)
- Dietary pattern(At infant age 6, 9, 12 and 15 months)
- Absenteeism (infant and parent)(Data collected continuously from enrollment until 15 months of age)