CClinicalTrials.gg
Not yet recruitingNCT05936112Cal-IBSUpdated Jul 7, 2023

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

An interventional study of Fecal calprotectin dosage and Questionnaire and interview with parents in Functional Gastrointestinal Disorders and Infant, Newborn, Diseases, sponsored by Centre Hospitalier Universitaire de Besancon. Not yet recruiting. Open to participants aged 0 Months to 4 Months. Per ClinicalTrials.gov, last updated 2023-07-07.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
0 Months to 4 Months
Sex
All
01

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.

02

Conditions studied

  • Functional Gastrointestinal Disorders
  • Infant, Newborn, Diseases
03

In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.

This study's planned enrollment of 100 is above the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 4 Months
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Infants < 4 months old with FGID

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

    Other: Fecal calprotectin dosage · Other: Questionnaire and interview with parents

  • Other
    Infants < 4 months old free from FGID

    Infants \< 4 months old without any Functional GastroIntestinal Disorder

    Other: Fecal calprotectin dosage · Other: Questionnaire and interview with parents

Interventions

  • OtherFecal calprotectin dosage

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

  • OtherQuestionnaire and interview with parents

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

06

What researchers measure

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

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05936112
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Jul 7, 2023
Start date
Sep 2023 (estimated)
Primary completion
Apr 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Jul 7, 2023

Study contacts

Laure CHEVENNEMENT COMMENT, Int
Contact
lchevennement@chu-besancon.fr
Eva OTT, MD
principal investigator · CHU de Besançon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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