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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

NCT05936112 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-07-07

No results posted yet for this study

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.

Conditions

  • Functional Gastrointestinal Disorders
  • Infant, Newborn, Diseases

Interventions

OTHER

Fecal calprotectin dosage

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

OTHER

Questionnaire and interview with parents

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Eva OTT, MD · CHU de Besançon

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-04-30
Completion
2024-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05936112 on ClinicalTrials.gov