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 (Cal-IBS)

Centre Hospitalier Universitaire de Besancon

Status: Not yet enrolling

Conditions: Functional Gastrointestinal Disorders; Infant, Newborn, Diseases

Treatments: Other: Fecal calprotectin dosage; Other: Questionnaire and interview with parents

Study type: Interventional

Funder types: Other

Identifiers

NCT05936112

2023/793

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 4 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Infants < 4 months old with FGID

Other group

Description:

Infants \< 4 months old presenting one or several Functional GastroIntestinal Disorder(s)

Treatment:

Other: Fecal calprotectin dosage

Other: Questionnaire and interview with parents

Infants < 4 months old free from FGID

Other group

Description:

Infants \< 4 months old without any Functional GastroIntestinal Disorder

Treatment:

Other: Fecal calprotectin dosage

Other: Questionnaire and interview with parents