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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Functional Gastrointestinal Disorders, Infant, Newborn, Diseases

Intervention / Treatment
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* Other: Fecal calprotectin dosage
* Other: Questionnaire and interview with parents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Infants < 4 months old with FGID<br>Infants < 4 months old presenting one or several Functional GastroIntestinal Disorder(s) | Other: Fecal calprotectin dosage<br>* Dosing calprotectin in infants' feces + questionnaire/interview with parents<br>Other: Questionnaire and interview with parents<br>* Dosing calprotectin in infants' feces + questionnaire/interview with parents<br>|
| Other: Infants < 4 months old free from FGID<br>Infants < 4 months old without any Functional GastroIntestinal Disorder | Other: Fecal calprotectin dosage<br>* Dosing calprotectin in infants' feces + questionnaire/interview with parents<br>Other: Questionnaire and interview with parents<br>* Dosing calprotectin in infants' feces + questionnaire/interview with parents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of fecal calprotectin concentration difference | 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 | 1 month |