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Cal-IBS: 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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05936112
Collaborator
(none)
100
Enrollment
2
Arms
7
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fecal calprotectin dosage
  • Other: Questionnaire and interview with parents
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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 in Besançon
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Infants < 4 months old with FGID

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

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
Other: Infants < 4 months old free from FGID

Infants < 4 months old without any Functional GastroIntestinal Disorder

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Months to 4 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Eva OTT, MD, CHU de Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT05936112
Other Study ID Numbers:
  • 2023/793
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 7, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Infant, Newborn, Diseases

Study Results

No Results Posted as of Jul 7, 2023