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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2024-04-30

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.

Detailed Description

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Conditions

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Functional Gastrointestinal Disorders Infant, Newborn, Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

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)

Group Type OTHER

Fecal calprotectin dosage

Intervention Type OTHER

Dosing calprotectin in infants' feces + questionnaire/interview with parents

Questionnaire and interview with parents

Intervention Type OTHER

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

Group Type OTHER

Fecal calprotectin dosage

Intervention Type OTHER

Dosing calprotectin in infants' feces + questionnaire/interview with parents

Questionnaire and interview with parents

Intervention Type OTHER

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

Intervention Type OTHER

Questionnaire and interview with parents

Dosing calprotectin in infants' feces + questionnaire/interview with parents

Intervention Type OTHER

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.
Minimum Eligible Age

0 Months

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva OTT, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Central Contacts

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Laure CHEVENNEMENT COMMENT, Int

Role: CONTACT

Other Identifiers

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2023/793

Identifier Type: -

Identifier Source: org_study_id

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