NCT05432479招募中不适用
A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
The Archer-Daniels-Midland Company4 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2022年9月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Change in cry and fuss time
研究概览
简要总结
This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.
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
- •Gestational age of minimum 37 weeks.
- •Birthweight of minimum 2500 g (5.5 lb.).
- •Age of greater than 3 weeks and less than 12 weeks at enrolment.
- •Confirmed Infantile colic defined as: parental report of crying and/or fussing ≥3 hours/day for ≥3 days/week, confirmed prior to enrolment with an infant behaviour diary recording >3 hours of crying in a 24-hour period (eDiary App completed daily during run-in period & for duration of study).
- •Participant Informed Consent form signed by parent or legal guardian.
- •Infant is considered healthy following physical exam.
- •Parents/Caregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits
排除标准
- •Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial.
- •Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics).
- •Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).
- •Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract.
- •Failure to thrive.
- •Known lactose or gluten intolerance.
- •Known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo.
- •Known other causes for abdominal pain (e.g., pyloric stenosis).
- •Participation in any other interventional clinical study.
- •Immuno-compromised participant or participant with other severe chronic disorder.
- •Use of probiotic supplements by breastfeeding mother from child's birth to enrolment.
- •Use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial.
- •Any Participant/Parent/Caregiver who is an employee of the investigational site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
结局指标
主要结局
Change in cry and fuss time
时间窗: Day 0 , Day 28
eDiary parent reported cry and fuss time
次要结局
- Change in cry and fuss time bouts(Day 0, Day 28)
- Change in the use of rescue medications(Day 0, Day 28)
- Resolution of colic symptoms(Day 0, Day 28)
- Change in sleeping time(Day 0 Day 28)
研究者
研究点 (4)
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