Quantification of Fecal Calprotectin Concentration Difference Between Infants Aged Under 4 Months Old Suffering From Functional Gastrointestinal Disorders (FGID) and Infants Aged Under 4 Months Old Free From Disorders : a Transversal Case-control Monocentric Study in Besançon
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Quantification of fecal calprotectin concentration difference
研究概览
简要总结
There is a high prevalence of FGID among infants : 30 % for regurgitations, 20 % for colitis , 15 % for functional constipation.This represents a frequent motive for pediatrics consultation : 23 to 28 % of medical consultations in this population are consequent to gastrointestinal symptoms among infants aged under 4 months old. This can lead to numerous inappropriate or unrecommended medication prescriptions.
Currently, fecal calprotectin threshold are only validated by science societies for children aged 5 years old and more. This study aims to quantify the difference of fecal calprotectin between a population of infants for whom no FGID has been finally detected, and a population of infants for whom FGID have been detected during the gastro-pediatrics consultation, , in order to later determine wether it is possible to validate a threshold in a population of infants aged under 4 months old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged under 4 months old benefiting from a special gastro-pediatrics consultation
- •FGID arm : infant with one or several FGID detected
- •Free from FGID arm : infant without any FGID detected
排除标准
- •Born before 37 week of amenorrhea.
- •Neurologic failure, heart failure, respiratory failure, hepatic failure, pancreatic failure, renal failure, cancer or hematological malignancy.
- •History of enteral feeding by tube (nasogastric, nasojejunal, gastrostomy, gastrostomy-jejunostomy, jejunostomy) or parenteral feeding.
- •History of digestive tract surgery
- •Suspicion of Immunoglobulin E-mediated Cow's Milk Protein Allergy (CMPA): anaphylactic-type reaction observed within a few minutes to 2 hours after ingestion of cow's milk protein, such as pruritus, erythema, angioedema, intense abdominal pain, projectile vomiting, acute diarrhea, bronchospasm, faintness, loss of consciousness, arterial hypotension or even anaphylactic shock.
研究组 & 干预措施
Infants < 4 months old with FGID
Infants < 4 months old presenting one or several Functional GastroIntestinal Disorder(s)
干预措施: Fecal calprotectin dosage (Other)
Infants < 4 months old with FGID
Infants < 4 months old presenting one or several Functional GastroIntestinal Disorder(s)
干预措施: Questionnaire and interview with parents (Other)
Infants < 4 months old free from FGID
Infants < 4 months old without any Functional GastroIntestinal Disorder
干预措施: Fecal calprotectin dosage (Other)
Infants < 4 months old free from FGID
Infants < 4 months old without any Functional GastroIntestinal Disorder
干预措施: Questionnaire and interview with parents (Other)
结局指标
主要结局
Quantification of fecal calprotectin concentration difference
时间窗: 1 month
Quantification in µg/g feces of fecal calprotectin concentration difference between infants aged under 4 months old suffering from Functional Gastrointestinal disorders (FGID) and infants aged under 4 months old free from disorders
次要结局
未报告次要终点