NCT02221687终止不适用
Evaluation of the Efficacy and Safety of an Infant Formula Containing Synbiotics and Its Effects on the Incidence of Infectious Diseases in the Infant Gut : a Double-blind, Randomized, Controlled Interventional Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 540
- 试验地点
- 25
- 主要终点
- (Cumulative) number of infectious diarrhea episodes per subject during the first year of life.
研究概览
简要总结
The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula.
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 5 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infants
- •Female or male gender
- •Gestational age between 37 and 41 weeks completed (= 41 weeks + 6 days)
- •Age at time of V1 visit : 4 +/- 7 days
- •Birth weight between 2500 ans 4200g, with regular weight gain (≥ 150g / week)
- •Two legal representatives (parent(s) / guardian(s)) who are capable of and willing to comply with the protocol and have signed the informed consent in accordance with legal requirements.
- •at least one of the legal representatives is affiliated to with a social security scheme.
- •Additionnaly , criteria of inclusion in one of the formula-fed groups or in the breast-fed group, respectively, are the following:
- •To be included in one of the formula arm, infants will have to be exclusively formula-fed (no breast milk meal) at the time of V1 visit (randomization).
- •To be included in the breastfeeding arm, infants will have to be exclusively breast-fed (no more than one formula meal per day) at V1 visit (randomization) and its mother will have to be willing to pursue exclusive breastfeeding at least until the infant will be 4-month old.
排除标准
- •Intensive care during at least the first 14 days of life
- •Neonatal health problems, such as: respiratory distress, asphyxia, hypoglycemia, sepsis, NEC (necrotizing enterocolitis),...
- •Clinical evidence of chronic illness or gastrointestinal disorders such as : GER (Gastrooesophageal Reflux), gastroenteritis,...
- •Known metabolic disorders, such as diabetes, lactose intolerance,....
- •Known immune deficiency
- •Subjects recommended to receive formula with hydrolized protein (e.g. children with allergy risk)
- •Subject under oral antibiotic treatment at V1 visit
- •Participation in another biomedical study
- •Whose legal representatives have psychological or linguistic incapability to sign the informed consent form
- •Reasons to presume that parents are unable to meet the study plan requirements (e.g. impossibility to contact study representatives in case of emergency, drug addiction etc)
研究组 & 干预措施
Synbiotic formula
Experimental
Synbiotic formula : standard formula enriched with a prebiotic fiber and a probiotic strain
Dose : variable number of powder scoops, adapted to the infant's age and weight, and addition of the defined amount of water, according to the Dose and Drinking Amount table.
Route : oral, ad libitum
Duration of product intake:
- Synbiotic IF : 5 months of consumption (from the inclusion until 6 months completed of age)
- Synbiotic FoF: 6 months of consumption (from 6 to 12 months of age)
干预措施: Synbiotic formula (Dietary Supplement)
Control formula
Placebo Comparator
Control formula : standard formula without pre and probiotic
Dose : variable number of powder scoops, adapted to the infant's age and weight, and addition of the defined amount of water according to the Dose and Drinking Amount table.
Route: oral, ad libitum
Duration of product intake:
- Control IF : 5 months of consumption (from the inclusion until 6 months completed of age)
- Control FoF : 6 months of consumption (from 6 to 12 months of age)
干预措施: Control formula (Dietary Supplement)
Breast-fed group
No Intervention
- Breast milk as exclusive feeding (no more than one formula meal per day), from birth until at least 4 months of age. Then, when the mother decides to stop breastfeeding, the infants can consume any formula on parent's choice respecting forbidden products list.
Dose:
- Breast milk : on demand
Route : oral, ad libitum
Duration of product intake:
- Breast milk : at least 4 month (from birth until at least 4 months of age)
结局指标
主要结局
(Cumulative) number of infectious diarrhea episodes per subject during the first year of life.
时间窗: one year
Difference between formula groups are evaluated via incidence rate based on number of subjects. In formula-fed infants, diarrhea is defined as three or more loose or watery stools in 24 hours with or without fever or vomiting (according to WHO and ESPGHAN definition). For breast-fed infants, a change in stool consistency versus previous stool consistency is more indicative of diarrhea than stool number. Diarrhea episode is considered as ended as soon as 2 consecutive non-watery stools are observed or no stools are observed in 24 hours.
次要结局
- Levels of fecal IgA and fecal calprotectin in planned stool samples(3 years)
- Adverse events (AE)(3 years)
- Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples(3 years)
- Characteristics of bowel movements during diarrhea episodes(1 year)
- Number and duration of antibiotic treatment.(1 year)
- Suitability for daily use(3 years)
- Infants growth measured by anthropometric measurements(3 years)
- Child's behavior(3 years)
- Minor gastrointestinal disorders (digestive tolerance)(3 years)
- Analysis of fecal microbiota by molecular analysis from frozen stools in diarrhea samples(1 year)
- Characteristics of bowel movements and stools(3 years)
- Number and duration of infectious diseases(1 year)
- Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples(3 years)
- Number and duration of fever episodes;(1 year)
- Number and duration of fever episodes;(3 years)
- Number and duration of antibiotic treatment.(3 years)
- Infants growth measured by anthropometric measurements(4 months)
- Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples(4 months)
- Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples(1 year)
- Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples(2 years)
- Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples(4 months)
- Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples(1 year)
- Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples(2 years)
- Characteristics of bowel movements and stools(4 months)
- Characteristics of bowel movements and stools(6 months)
- Characteristics of bowel movements and stools(9 months)
- Infants growth measured by anthropometric measurements(4 weeks)
- Characteristics of bowel movements and stools(1 year)
- Characteristics of bowel movements and stools(2 years)
- Levels of fecal IgA and fecal calprotectin in planned stool samples(4 months)
- Levels of fecal IgA and fecal calprotectin in planned stool samples(1 year)
- Levels of fecal IgA and fecal calprotectin in planned stool samples(2 years)
- Number and duration of infectious diseases(3 years)
- Infants growth measured by anthropometric measurements(6 months)
- Infants growth measured by anthropometric measurements(9 months)
- Infants growth measured by anthropometric measurements(1 year)
- Infants growth measured by anthropometric measurements(2 years)
- Child's behavior(4 months)
- Child's behavior(6 months)
- Child's behavior(9 months)
- Child's behavior(1 year)
- Child's behavior(2 years)
- Minor gastrointestinal disorders (digestive tolerance)(4 months)
- Minor gastrointestinal disorders (digestive tolerance)(6 months)
- Minor gastrointestinal disorders (digestive tolerance)(9 months)
- Minor gastrointestinal disorders (digestive tolerance)(1 year)
- Minor gastrointestinal disorders (digestive tolerance)(2 years)
- Suitability for daily use(4 months)
- Suitability for daily use(6 months)
- Suitability for daily use(9 months)
- Suitability for daily use(1 year)
- Suitability for daily use(2 years)
- Adverse events (AE)(4 months)
- Adverse events (AE)(6 months)
- Adverse events (AE)(9 months)
- Adverse events (AE)(1 year)
- Adverse events (AE)(2 years)
研究者
研究点 (25)
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