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

Not Applicable

Not yet recruiting

• Conditions: Functional Gastrointestinal Disorders; Infant, Newborn, Diseases
• Interventions: Other: Fecal calprotectin dosage; Other: Questionnaire and interview with parents

• Registration Number: NCT05936112
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-06-30
• Last Update Submitted: 2023-06-30
• Study First Posted: 2023-07-07
• Last Update Posted: 2023-07-07
• Study Start: 2023-09
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infants < 4 months old with FGID	Questionnaire and interview with parents	Infants \< 4 months old presenting one or several Functional GastroIntestinal Disorder(s)
Infants < 4 months old free from FGID	Questionnaire and interview with parents	Infants \< 4 months old without any Functional GastroIntestinal Disorder
Infants < 4 months old with FGID	Fecal calprotectin dosage	Infants \< 4 months old presenting one or several Functional GastroIntestinal Disorder(s)
Infants < 4 months old free from FGID	Fecal calprotectin dosage	Infants \< 4 months old without any Functional GastroIntestinal Disorder

Primary Outcome Measures

Name	Time	Method
Quantification of fecal calprotectin concentration difference	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