Double-blind, Randomized Placebo-controlled Trial for the Preventive Effect of Limosilactobacillus Reuteri (L. Reuteri) on Excessive Crying and Colic in Healthy Infants.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 768
- 试验地点
- 1
- 主要终点
- Peak measured crying time
研究概览
简要总结
This study aims to demonstrate that a dietary supplement, which contains two strains of the probiotic L. reuteri is safe, well tolerated and able to reduce the incidence of colic and excessive crying/fussiness in healthy infants. Additionally, the study aims to investigate if children with this probiotic supplement have better stool characteristics and a more beneficial composition of the fecal and skin flora than children given a placebo during the first 3 months of life.
详细描述
This study is a double-blind, randomized, placebo-controlled trial conducted at UZ Brussel to evaluate the safety and preventive efficacy of a dietary supplement containing two probiotic strains of Limosilactobacillus reuteri on excessive crying and the development of infantile colic in healthy newborns.
Recent systematic reviews and meta-analyses have shown that supplementation with certain strains of L. reuteri significantly reduces crying and fussing time in infants. A novel formulation combining those strains was developed to achieve a potentially enhanced effect on infant distress symptoms. This study investigates whether early supplementation, initiated within the first week of life, is safe and effective during the first three months of life.
Healthy, full-term infants (≥37 weeks' gestation) aged 1-14 days at inclusion are eligible. Participants are randomized to receive either placebo plus vitamin D (400 IU) or L. reuteri plus vitamin D (400 IU) for a maximum of 98 days, until approximately 3 months of age.
Study visits include a baseline visit (day 1-14), a midway visit at 6 weeks, an end-of-intervention visit at 3 months, and a long-term follow-up at 1 year. Additional telephone contacts are triggered by infant day diaries.
The primary outcomes are peak crying and fussing time at 6 weeks of age and the occurrence of infantile colic during the first 3 months of life. Secondary outcomes include infant quality of life (ITQOL™), parental stress, parental satisfaction, crying and fussiness patterns, and the presence of atopic dermatitis. Exploratory outcomes assess changes in the intestinal microbiome, stool characteristics, biomarkers, growth, and allergy-related parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks.
- •Infant is healthy at the time of pre-examination.
- •Infant is aged between 1 and 14 days old at the time of inclusion.
- •Legal guardian(s) are able and willing to follow the study instructions
- •Infant is suitable for participation in the study according to the investigator/ study personnel
- •Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3).
- •Informed written consent given by parent / legal guardian
排除标准
- •No legal guardian's command of any local language
- •Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e. Hirschsprung's disease, metabolic disorder)
- •Infant is suffering from congenital or acquired immunodeficiency
- •Infant is suffering from an infection at the time of pre-examination or previous 7 days
- •Infant is admitted post-partum to the neonatal intensive care unit
- •Infant is not suitable for participation in the study according to the study personnel´s opinion
研究组 & 干预措施
Control group
The control groups gets no Limosilactobacillus reuteri
干预措施: Placebo (Dietary Supplement)
Intervention group
The intervention group gets the two probiotic Limosilactobacillus reuteri strains
干预措施: Two probiotic Limosilactobacillus reuteri strains (Dietary Supplement)
结局指标
主要结局
Peak measured crying time
时间窗: 6 weeks
Peak measured crying time at 6 (±1) weeks according to the prospectively kept baby day diary
The occurrence of infant colic at any time in the first 3 months of life.
时间窗: 3 months
The criteria for infant colic are: * Recurrent and prolonged periods of infant crying, fussing, or irritability reported by caregivers that occur without obvious cause and cannot be prevented or resolved by caregivers. Fussing refers to intermittent distressed vocalization and refers to behavior that is not quite crying but not awake and content either. * Caregiver reports infant has cried or fussed for 3 or more hours/day during 3 or more days in a given week. * Total 24-hour crying plus fussing in the selected group of infants is confirmed to be 3 hours or more when measured by at least one, prospectively kept, 24-hour behavior diary.
次要结局
- Peak measured fussiness time(6 weeks)
- Overall crying and/or fussiness time(3 months)
- Overall unconsolable crying time(3 months)
- Parental stress(3 months)
- Quality of Life score(12 months)
- Parental satisfaction(3 months)
- Atopic dermatitis(12 months)