Actively Recruiting

Phase Not Applicable
Age: 0 - 4Months
All Genders
ID06488274

Assessment of Functional Gastrointestinal Disorders in Infants Using a New Infant Formula An Interventional Study to Track Symptom Evolution During Dietary Management

Led by United Pharmaceuticals · Updated on 2025-01-06

139

Participants Needed

4

Research Sites

75 weeks

Total Duration

On this page

Sponsors

U

United Pharmaceuticals

Lead Sponsor

A

Axiodis CRO

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the development of functional gastrointestinal disorders (FGIDs) in infants who are fed a new infant formula. This research uses the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale to measure these disorders. The study is interventional, open-label, and involves multiple centers, focusing on infants with FGIDs as defined by adapted Rome IV criteria. The study includes a treatment period where infants receive the new infant formula over a total of four months. The study is divided into an initial 30-day period followed by an optional 90-day intervention period. The formula is provided as a dietary supplement specifically designed for this study. During the study, caregivers and researchers will monitor the infants' gastrointestinal symptoms using the GIGER scale, with the primary outcome assessed on day 30. Participants' progress and any changes in symptoms will be evaluated throughout the intervention. Safety and adherence to the feeding regimen will also be observed to better understand the formula's impact on FGIDs.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 4Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants with at least one functional gastrointestinal disorder (regurgitations, colic, or constipation) based on adapted Rome IV criteria
  • Born at 35 weeks or more of gestational age
  • Up to 4 months of age
Not Eligible

You will not qualify if you...

  • Exclusively or partially breastfed infants with more than 2 breast feeds per day and maternal willingness to continue breastfeeding
  • Infants who are diversified or whose parents plan to start diversification within 2 weeks of the study
  • Use of antibiotics at inclusion visit or within 7 days before
  • Plans to take additional prebiotics, probiotics, or thickening agents during the study
  • Known allergy or intolerance to any ingredient of the product or suspected cow's milk allergy requiring an eviction diet
  • Any other condition or participation in another clinical trial that the investigator believes may interfere or pose risk during the study

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Site 02

Nice, France

Not Yet Recruiting

2

Site 04

Paris, France

Not Yet Recruiting

3

Site 03

Toulon, France

Actively Recruiting

4

Site 01

Vincennes, France

Actively Recruiting

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Research Team

A

Anne-Sophie Garreau

C

Caroline Thevret, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial

[Evaluation of the quality of life of infants and very young children: validation of a questionnaire. Multicenter European study].

S Manificat, A Dazord, J Langue...

https://pubmed.ncbi.nlm.nih.gov/10911526
Assessment of Functional Gastrointestinal Disorders in Infants Using a New Infant Formula An Interventional Study to Track Symptom Evolution During Dietary Management | DecenTrialz