NCT05936112

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

July 7, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

June 30, 2023

Last Update Submit

June 30, 2023

Conditions

Functional Gastrointestinal DisordersInfant, Newborn, Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

    1 month

Study Arms (2)

Infants < 4 months old with FGID

OTHER

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

Other: Fecal calprotectin dosageOther: Questionnaire and interview with parents

Infants < 4 months old free from FGID

OTHER

Infants \< 4 months old without any Functional GastroIntestinal Disorder

Other: Fecal calprotectin dosageOther: Questionnaire and interview with parents

Interventions

Fecal calprotectin dosageOTHER

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

Infants < 4 months old free from FGIDInfants < 4 months old with FGID
Questionnaire and interview with parentsOTHER

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

Infants < 4 months old free from FGIDInfants < 4 months old with FGID

Eligibility Criteria

Age0 Months - 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastrointestinal DiseasesInfant, Newborn, Diseases

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Digestive System DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Eva OTT, MD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure CHEVENNEMENT COMMENT, Int

CONTACT

lchevennement@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2023

First Posted

July 7, 2023

Study Start

September 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

July 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share