Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Daily Average Crying and Fussing Duration According to Barr Diary Records
研究概览
简要总结
This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with Lactobacillus GG (LGG)) during 3 months of formula feeding. The investigators' aims are to compare 3 outcomes in these babies: (1) normal baby crying time; (2) the composition of intestinal microbiota (bacteria in the stool); and (3) a lab test which measures the number of white blood cells in the large intestine (fecal calprotectin). The investigators predict that LGG supplementation (Nutramigen-Enflora) will facilitate its establishment as an important component of the neonatal intestinal microbial community and reduce fecal calprotectin.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Sixty healthy full-term colicky infants (gestational age 32 wks to 41 wks)
排除标准
- •chronic lung disease,
- •diarrhea (stools that take the shape of a container > 5x daily)
研究组 & 干预措施
Nutramigen Lipil with Enflora
Formula with probiotics (Lactobaccillus Rhamnosus GG)
干预措施: Nutramigen with Enflora (Dietary Supplement)
Nutramigen A+
Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)
干预措施: Nutramigen A+ (Dietary Supplement)
结局指标
主要结局
Daily Average Crying and Fussing Duration According to Barr Diary Records
时间窗: 90 days
The parent or guardian will complete a Barr diary to measure crying and fussing times of colicky infants . It is a daily timeline that records the number of minutes in five minute increments with fussiness and crying. The average colicky infant cries and fusses is more than 3 hours daily. If infants surpasses the 3 hours for more than three days (not consecutive) and are less than 3 months of age, they are considered to have colic.
次要结局
- Fecal Microbiota(90 days)
- Fecal Calprotectin(90 days)
研究者
J. Marc Rhoads
Professor - Pediatrics, Gastroenterology
The University of Texas Health Science Center, Houston