Effect of First Complementary Foods on the Infant Gastrointestinal Microbiota: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change in gastrointestinal microbiota
研究概览
简要总结
This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.
详细描述
The introduction of solid foods plays a role in shaping the microbial communities of the gastrointestinal microbiota. This randomized, controlled, single-blinded trial will evaluate the effect of four infant foods (oatmeal cereal, carrot puree, prune puree, beef and gravy puree) on the gastrointestinal microbiota of exclusively human milk fed infants that have not previously consumed solid foods and who are developmentally ready for the introduction of solid foods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant was born vaginally
- •Infant was born full term
- •Infant has no significant gastrointestinal medical issues/diagnoses (e.g., gastroesophageal reflux, malabsorption syndromes, Celiac disease, Crohn's disease, or physician diagnosed or suspected food allergies)
- •Infant is at least 5 months old, but not 8 or more months old
- •Infant consumes an exclusively human milk liquid diet only
- •Infant has not yet begun consuming solid foods
- •Infant is developmentally ready to begin consuming solid foods (i.e., has good head and neck control, can sit upright when supported, and has at least doubled their birth weight)
- •Infant has not had antibiotics within the past month
- •Infant's nursing mother has not had antibiotics within the past month
- •Parent/legal guardian is at least 18 years old
排除标准
- •Infant is not developmentally ready to begin solid foods
- •Infant has a family history of food allergy
研究组 & 干预措施
Infant cereal
Oatmeal cereal
干预措施: Infant grain (Other)
Infant fruit
Pureed prunes
干预措施: Infant fruit (Other)
Infant vegetable
Pureed carrots
干预措施: Infant vegetable (Other)
Infant meat
Pureed beef
干预措施: Infant meat (Other)
结局指标
主要结局
Change in gastrointestinal microbiota
时间窗: Day 0, 3, 7, 10, 14
Composition of the gastrointestinal microbiota (family, genus, and species levels via shotgun metagenomic sequencing) before and after the introduction of solid food
次要结局
未报告次要终点
研究者
Jill Trabulsi
Associate Professor
University of Delaware