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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-21

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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The study comprises a first period of 30 days followed by an optional intervention period of 90 days.

Conditions

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Functional Gastrointestinal Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Interventional, open-label, non-comparative multicenter study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Test formula

The test product is a thickened infant formula containing symbiotic (fibers and probiotics)

Group Type EXPERIMENTAL

New infant formula

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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New infant formula

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Infants presenting with at least one of the FGIDs below, defined based on adapted Rome IV criteria as follows:

1.1 Regurgitations: 1.2 Colic: 1.3 Constipation:
2. Infants born at 35 weeks or more of gestational age
3. Infants up to 4 months of age

Exclusion Criteria

1. Exclusively or partially breastfed infants (i.e. \&amp;gt; 2 breast feeds per day) with maternal willingness to continue breastfeeding
2. Diversified infants or whose parents intend to start diversification within the first 2 weeks of the study
3. Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusion visit (V0)
4. The willingness to take additional pre-, probiotics or thickening agents during the study
5. Known allergy/intolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet
6. Infants presenting with any other situation including the participation in another clinical trial, which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the patient

(non exhaustive list)

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No