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Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula

NCT06488274 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2025-01-06

No results posted yet for this study

Summary

This study aims to assess the evolution of functional gastrointestinal disorders (FGIDs) in infants fed with a new infant formula, using the Gastrointestinal (GI) and gastroesophageal reflux (GER) (GIGER) scale through an interventional, open-label, non-comparative multicenter study.

Conditions

  • Functional Gastrointestinal Disorders

Interventions

DIETARY_SUPPLEMENT

New infant formula

The new formula will be given to infants during the 4-month study period.

Sponsors & Collaborators

  • Axiodis CRO

    collaborator UNKNOWN

  • United Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Christophe Batard, Dr. · Ambulatory pediatrician in Vincennes (France)

  • Camille Jung, Prof. · Centre Hospitalier Intercommunal (CHI) in Créteil (France)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2025-12-31
Completion
2026-04-30

Countries

  • France

Study Locations

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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 NCT06488274 on ClinicalTrials.gov