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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 (Cal-IBS)

Primary Purpose

Functional Gastrointestinal Disorders, Infant, Newborn, Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fecal calprotectin dosage
Questionnaire and interview with parents
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Functional Gastrointestinal Disorders

Eligibility Criteria

0 Months - 4 Months (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Infants < 4 months old with FGID

    Infants < 4 months old free from FGID

    Arm Description

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

    Infants < 4 months old without any Functional GastroIntestinal Disorder

    Outcomes

    Primary Outcome Measures

    Quantification of fecal calprotectin concentration difference
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2023
    Last Updated
    June 30, 2023
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05936112
    Brief 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
    Acronym
    Cal-IBS
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Gastrointestinal Disorders, Infant, Newborn, Diseases

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Infants < 4 months old with FGID
    Arm Type
    Other
    Arm Description
    Infants < 4 months old presenting one or several Functional GastroIntestinal Disorder(s)
    Arm Title
    Infants < 4 months old free from FGID
    Arm Type
    Other
    Arm Description
    Infants < 4 months old without any Functional GastroIntestinal Disorder
    Intervention Type
    Other
    Intervention Name(s)
    Fecal calprotectin dosage
    Intervention Description
    Dosing calprotectin in infants' feces + questionnaire/interview with parents
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire and interview with parents
    Intervention Description
    Dosing calprotectin in infants' feces + questionnaire/interview with parents
    Primary Outcome Measure Information:
    Title
    Quantification of fecal calprotectin concentration difference
    Description
    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
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Months
    Maximum Age & Unit of Time
    4 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laure CHEVENNEMENT COMMENT, Int
    Email
    lchevennement@chu-besancon.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eva OTT, MD
    Organizational Affiliation
    CHU de Besançon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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

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