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

Not Applicable

Recruiting

• Conditions: Functional Gastrointestinal Disorders
• Interventions: Dietary Supplement: New infant formula

• Registration Number: NCT06488274
• Lead Sponsor: United Pharmaceuticals

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-05
• Study Start: 2024-10-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-12
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 139

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. > 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test formula	New infant formula	The test product is a thickened infant formula containing symbiotic (fibers and probiotics)

Primary Outcome Measures

Name	Time	Method
Change from baseline of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale score	Day 30	The main outcome will be the evolution of the sum score of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale (Pados et al., 2021). The GIGER score varies from 0 to 180 being the worst.

Secondary Outcome Measures

Name	Time	Method
Regurgitation severity	Day 14, Day 30, Day 60, Day 90, Day 120	The regurgitation severity will be assessed using the adapted Vandenplas regurgitation score (from 0 to 6 being the worst) (Vandenplas et al., 1994) over the last 3 days preceding each visit.
Investigator's evaluation of the evolution of FGIDs	Day 14, Day 30, Day 60, Day 90, Day 120	The investigator will evaluate the evolution of each FGID (i.e. regurgitations, constipation, colic) using a 4-point scale (Improvement; Worsening; No evolution; Not applicable) over the past period.
Stool frequency and consistency in non constipated infant	Day 7, Day 14, Day 30, Day 60, Day 90, Day 120	If the infant is not constipated at inclusion and during the study, the average main stool consistency will be assessed based on the BITSS scale (Brussels Infant and Toddler Stool Scale) as well as the daily average number of stools over the last 3 days.; The BITTS scale is a reliable instrument to assess stools of non-toilet trained children. It consists of 7 color photographs of diapers containing stools from infants and toddlers categorized as Hard, Formed, Loose, or Watery (Huysentruyt et al., 2019).
Stool frequency and consistency in constipated infant	Day 7, Day 14, Day 30, Day 60, Day 90, Day 120	If the infant is constipated at one visit during the study, the total number of each stool consistency will be assessed for the next visit based on the BITSS scale over the last 7 days. The total number of stools over the last 7 days will be calculated.
Colic	Day 7, Day 14, Day 30, Day 60, Day 90, Day 120	Colic will be assessed through unexplained crying duration and fussing/irritability duration on average over the last 3 days and reported based on a 4-point scale (\< 1h; 1h-2h; 2h-3h; \> 3h).
Abdominal distension severity	Day 7, Day 14, Day 30, Day 60, Day 90, Day 120	Abdominal distension is defined as a swollen, tense and hard to the touch stomach. Its severity will be assessed on average over the last 3 days using a visual analog scale (from 0=No symptom to 10=Very severe symptoms).
GIGER score	Day 7, Day 14, Day 60, Day 90, Day 120	Evolution of Gastrointestinal and Gastroesophageal Reflux (GIGER) scale total score (from 0 to 180) and 3 subscores (subscore 1: from 0 to 75; subscore 2: from 0 to 65; subscore 3: from 0 to 40) from baseline. The higher the GIGER is, the worst the symptoms are.
Number of bottles at night	D7, D14, D30, D60, D90, D120	The number of bottles at night will be recorded on average over the last 3 days.
Parents' satisfaction	Day 7, Day 14, Day 30, Day 60, Day 90, Day 120	Parents' satisfaction will be assessed on the product use and acceptability using a 5-point Likert scale and more specifically on the evolution of each FGID (i.e. regurgitations, constipation, colic) using a 4-point scale (Improvement; Worsening; No evolution; Not applicable) over the past period.
Regurgitation frequency	Day 7, Day 14, Day 30, Day 60, Day 90, Day 120	The number of daily regurgitation episodes and the daily volume of regurgitation will be assessed on average over the last 3 days. The frequency of regurgitations away from meals and of continuous regurgitations of small volumes after feeding will be assessed on average over the last 3 days via a 4-point scale \[Never; Rarely; Often; Always\].
Weight	Day 30, Day 60, Day 90, Day 120	Weight will be expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards.
Height	Day 30, Day 60, Day 90, Day 120	Height will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Gas/flatulence severity	Day 7, Day 14, Day 30, Day 60, Day 90, Day 120	Gas/flatulence severity will be assessed on average over the last 3 days using a visual analog scale (from 0=No symptom to 10=Very severe symptoms).
BMI	Day 30, Day 60, Day 90, Day 120	BMI will be expressed in value and z scores according to the WHO Child Growth Standards.
Evolution of FGIDs (regurgitations, colic and constipation)	Day 14, Day 30, Day 60, Day 90, Day 120	FGIDs such as regurgitation, colic and constipation will be assessed according to adapted Rome IV criteria. The improvement and complete resolution timeframe of each FGID present at inclusion and/or occurring during the study will be determined.
Defecation pain frequency in constipated infant	Day 7, Day 14, Day 30, Day 60, Day 90, Day 120	If the infant is constipated at one visit during the study, the frequency of defecation pain will be assessed for the next visit based on a 3-point scale (No; Yes, only 1 time; Yes, \>1 time) over the last 7 days.
Infant's quality of life	Day 7, Day 14, Day 30, Day 60, Day 90, Day 120	Parents will complete the QUALIN questionnaire (score from -68 to +68) (Manificat et al., 2000) over the last week.
Adverse events	Through study completion (up to 30 days or 120 days if participation to the optional intervention period)	Any untoward medical reaction occuring from the signatture of the consent until the end of the participant's participation
Sleep	Day 7, Day 14, Day 30, Day 60, Day 90, Day 120	The average sleep duration will be reported over the last 3 days and sleep quality will be assessed using a visual analog scale (from 0= Difficult to fall asleep, frequent awakenings to 10= Easy and quick falling asleep, no awakenings without obvious cause).
Head circumference	Day 30, Day 60, Day 90, Day 120	Head circumference will be expressed in cm and in z scores according to the WHO Child Growth Standards.

Trial Locations

Locations (4)

Site 02; 🇫🇷 Nice, France

Site 04; 🇫🇷 Paris, France

Site 03; 🇫🇷 Toulon, France

Site 01; 🇫🇷 Vincennes, France