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
NCT ID: NCT05936112
Last Updated: 2023-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2023-09-30
2024-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Infants < 4 months old with FGID
Infants \< 4 months old presenting one or several Functional GastroIntestinal Disorder(s)
Fecal calprotectin dosage
Dosing calprotectin in infants' feces + questionnaire/interview with parents
Questionnaire and interview with parents
Dosing calprotectin in infants' feces + questionnaire/interview with parents
Infants < 4 months old free from FGID
Infants \< 4 months old without any Functional GastroIntestinal Disorder
Fecal calprotectin dosage
Dosing calprotectin in infants' feces + questionnaire/interview with parents
Questionnaire and interview with parents
Dosing calprotectin in infants' feces + questionnaire/interview with parents
Interventions
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Fecal calprotectin dosage
Dosing calprotectin in infants' feces + questionnaire/interview with parents
Questionnaire and interview with parents
Dosing calprotectin in infants' feces + questionnaire/interview with parents
Eligibility Criteria
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Inclusion Criteria
* FGID arm : infant with one or several FGID detected
* Free from FGID arm : infant without any FGID detected
Exclusion Criteria
* 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.
0 Months
4 Months
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Eva OTT, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Besançon
Central Contacts
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Other Identifiers
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2023/793
Identifier Type: -
Identifier Source: org_study_id
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