NCT07190859招募中不适用
A Double-blind, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- BioGaia AB
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Crying and fussing time
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 3-12 weeks at screening.
- •Gestational age 37+0 weeks - 42+0 weeks at birth.
- •Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.
- •Parents/caregivers/legal guardians are >18 years.
- •Exclusively or predominantly breastfed infants (> 50 % breast fed).
- •Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.).
- •Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires.
- •Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents/caregivers/legal guardians must report that their infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week). At Visit 2, this will be confirmed by Baby's Day Diary®, at least one 24-hour period should show 3 or more hours of crying/fussing time.
- •Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
- •Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study.
- •The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 3 (Day 8), and Visit 4 (Day 22).
- •Infant is considered healthy, in the opinion of the investigator following physical exam.
排除标准
- •Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis).
- •Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container > 12x in breastfed and >5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents/caregivers/ legal guardians.
- •Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
- •Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
- •Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
- •Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.
结局指标
主要结局
Crying and fussing time
时间窗: From baseline to Day 7
Change in mean crying and fussing time as assessed by the Baby's Day Diary
次要结局
- Crying and fussing time(From baseline up to Day 21)
- Number of responders(From baseline up to Day 21)
- Family Quality of Life(From baseline up to Day 21)
- Maternal depression(From baseline up to Day 21)
- Sleeping time(From baseline up to Day 21)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With ColicInfantile ColicNCT06462651BioGaia AB50
已完成
2 期
A Trial Investigating the Effect of 4 Weeks Dosing of XEN-D0501 on Blood Glucose Reduction in Patients With DiabetesEfficacySafetyPharmacokineticsDiabetes Mellitus, Type 2NCT05353686Pila Pharma54
招募中
不适用
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With ColicColic, InfantileNCT05512234BioGaia AB102
已完成
不适用
Study to Assess Effects of Postbiotic vs Placebo in Participants With Diarrhea-predominant IBSDiarrhea-Predominant Irritable Bowel SyndromeNCT06346847A-Mansia Biotech S.A.384
已完成
不适用
A Study to Assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults With Functional ConstipationFunctional ConstipationNCT06730594Vedic Lifesciences Pvt. Ltd.168