NCT04765852已完成不适用
Growth, Safety and Efficacy of a Probiotic Supplement: a Double-blind, Randomized, Placebo-controlled Trial
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2021年2月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Safety of high dose probiotic supplement (weight gain)
研究概览
简要总结
The primary objective of the study is to demonstrate the safety of a daily high dose of a probiotic supplement by comparing the growth (weight gain, g/day) of formula-fed and/or breastfed infants in high dose group versus placebo group from enrolment to 8 weeks of intervention
详细描述
This is a randomized, placebo-controlled, double-blind study of healthy term infants, consisting of three randomized arms: placebo control group, high dose experimental group, and low dose experimental group. The study population, approximately 228, are infants 14 - 21 days of age who are formula-fed and/or breastfed who is aligned with the intended target population for a probiotic supplement. Placebo and probiotic supplements will be mixed with formula or breastmilk and fed orally using a feeding cup or syringe. All enrolled infants will participate in the trial for approximately 8 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Days 至 21 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 can be contacted directly by telephone throughout the study.
- •Infants whose parent(s)/LAR have access to a working freezer.
- •Infants must meet all the following inclusion criteria to be eligible for enrolment into the study:
- •Healthy term (37-42 weeks of gestation) infant at birth.
- •At enrolment visit, post-natal age 14-21 days (date of birth = day 0)
- •Birth weight ≥ 2500g and ≤ 4500g.
- •Breastfed and/or formula-fed infants (including exclusively and mixed fed breast- and formula-fed infants) whose parent(s)/LAR intent not to change the feeding regimen until the study end at 8 weeks of intervention.
- •Formula-fed infants and their parent(s)/LAR must have independently elected, before enrolment not to breastfeed and their infant must tolerate a standard cow's milk infant formula not containing any probiotics at time of enrolment.
排除标准
- •Infants with conditions requiring specific infant feeding regimens 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 enrollment.
- •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).
- •History of admission to the Neonatal Intensive Care Unit (NICU), except for admission for jaundice phototherapy.
- •Other 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.
- •Infants who are presently receiving or have received prior to enrollment 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 (e.g., 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.
结局指标
主要结局
Safety of high dose probiotic supplement (weight gain)
时间窗: Day 56
Compare the growth (weight gain, g/day) of formula-fed and/or breastfed infants in EG 1 vs. CG from enrolment to 8 weeks of intervention
次要结局
- Efficacy of two different doses of probiotic supplement(Day 0, Day 25-27, Day 53-55)
研究者
研究点 (2)
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