Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- 45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status.
研究概览
简要总结
This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.
详细描述
This study will evaluate the safety and tolerability of Lactobacillus reuteri in healthy infants with colic. Patients will be randomized to receive either L. reuteri at one dose orally for a total of 42 doses. The doses will be 5x108 (5 drops) during a satisfactory assessment of safety and tolerability. The time on study treatment is 6 months, and the target sample size is 45 healthy infants.
Secondly, the investigators aim to gather evidence supporting hypothesis of safety and tolerability of Lactobacillus reuteri by administering a physical examination and testing of complete blood count, liver tests, and serum electrolytes over a forty-two day period.
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 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full-term babies with colic (21-90 days old, who cry/fuss > 3h daily x > 3d wk)
- •baby must have more than 3h crying for enrollment
排除标准
- •severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis)
- •failure to thrive
- •intrauterine growth retardation
- •hematochezia (blood in the stools)
- •diarrhea (watery stools that takes the shape of a container > 5x daily)
- •fever (38.2 degrees)
- •Premature infants (<37 wk gestation)
研究组 & 干预措施
Sunflower Oil
The second arm includes 15 subjects on placebo (sunflower oil.)
干预措施: Placebo (Biological)
Lactobacillus reuteri
The first arm of the cohort will include 30 patients on LR (5x10^8 cfu's orally once daily.)
干预措施: Lactobacillus reuteri (Biological)
结局指标
主要结局
45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status.
时间窗: 92 days
1. Physical Examination of infants will be performed to evaluate any adverse effects of LR. 2. Electrolyte testing at baseline will evaluate for any inborn error of fluid and electrolyte balance and at end of treatment will evaluate for any adverse impact of LR in the subjects.
次要结局
- Determine effect of L. reuteri in 45 infants with colic on gastrointestinal inflammation as assessed by fecal calprotectin.(1, 42 & 92 days)
研究者
J. Marc Rhoads
Director, Pediatric Gastroentrologist
The University of Texas Health Science Center, Houston