Prospective Study to Determine the Factors Influencing Infant Colic Course in Infants Taking Probiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 4
- 主要终点
- Duration of crying and fussing
研究概览
简要总结
Randomized study to determine the effect of a commercialized combination of 2 probiotic strains (Bifidobacterium Longum and Pediococcus pentosaceus) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria when administered for 21 days.
详细描述
Randomized, single-blind, interventional study with two parallel groups to determine the effect of two different commercialized probiotic products (Lactobacillus reuteri or a combination of two different strains (Bifidobacterium longum and Pediococcus pentosaceus)) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria. Infants meeting selection criteria are randomized 1:1 and stratified according to the type of feeding (breastfed or formula).
Probiotics are administered once a day (5 drops) for 21 days. Parents must document clinical parameters during this 21 days. This parameters include colic-related symptoms, other functional gastrointestinal disorders symptoms, parental anxiety and adverse events.
Moreoever, stool samples are collected to determine intestinal microbiota and calprotectin levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Both probiotic products will be provided in their commercial form. Both products will be individually placed inside opaque bags so that the investigator can not recognize the external case.
入排标准
- 年龄范围
- 2 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants from 2 to 12 weeks of age
- •Infants diagnosed with infant colic following Roma IV criteria for clinical research
- •Gestational age greater or equal to 37 weeks
- •Birth weight greater than 2100 g
- •Exclusively breastfed or formula fed with a maximum of one daily intake of breast milk.
排除标准
- •Infants that are fed with solid food.
- •Infants whose parents can not appropriately follow the requirements of the study.
- •Antibiotics or probiotics administration to the infant (including infant formula with probiotics) 2 weeks prior the inclusion in the study.
- •Breastfed infants whose mothers have taken antibiotics and/or probiotics 2 weeks prior the inclusion in the study.
- •Infants fed extensively hydrolyzed infant formula
- •Specific medication use for the treatment of functional digestive disorder: antacids (IBP type or H2 blockers), laxative Polyethylene glycol (8PEG), lactulose, magnesia), lactase or simeticone.
- •Infants going through therapies related with acupuncture, homeopathy, medicinal herbs, or taking anti-inflammatory or antispasmodic drugs.
研究组 & 干预措施
AB- Kolicare
Probiotic multi-strain formulation comprising Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330 in sunflower oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority
干预措施: AB-Kolicare (Dietary Supplement)
Reuteri gotas
Probiotic single-strain formulation comprising Lactobacillus reuteri DSM17938 in sunflower oil and medium-chain triglyceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority
干预措施: Reuteri gotas (Dietary Supplement)
结局指标
主要结局
Duration of crying and fussing
时间窗: 21 days
Change on daily crying and fussing minutes measured through Barr ( Barr et al., 1988).validated crying and fussing scale. The Barr scale consists of a 24 hours dairy where parents paint number of hours crying and fussing every day. Results show the number of hours of crying and fussing per day.
Percent of responders
时间窗: 7, 14, 21 days
Percent of subjects whose change in crying time is equal or larger than 50% from baseline
次要结局
- Number of regurgitations(21 days)
- Parent's anxiety and depression(baseline, day 21)
- Fecal microbiome(baseline, day 21)
- Food intake(21 days)
- Fecal calprotectin(baseline, day 21)
- Bowel movements(21 days)
- Adverse events(21 days)