Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
NCT Number: NCT06488274
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Functional Gastrointestinal Disorders
Interventions: DIETARY_SUPPLEMENT: New infant formula
Sponsor: United Pharmaceuticals
Collaborators: Axiodis CRO
Sex: ALL
Age: CHILD
Enrollment: 139
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07
Completion Date: 2026-04

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.

Primary Outcome Measures: Change from baseline of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale score, 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., Day 30
Secondary Outcome Measures: Evolution of FGIDs (regurgitations, colic and constipation), 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., Day 14, Day 30, Day 60, Day 90, Day 120|Regurgitation frequency, 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 \[Never; Rarely; Often; Always\]., Day 7, Day 14, Day 30, Day 60, Day 90, Day 120|Regurgitation severity, 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., Day 14, Day 30, Day 60, Day 90, Day 120|Stool frequency and consistency in non constipated infant, 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)., Day 7, Day 14, Day 30, Day 60, Day 90, Day 120|Stool frequency and consistency in constipated infant, 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., Day 7, Day 14, Day 30, Day 60, Day 90, Day 120|Defecation pain frequency in constipated infant, 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., Day 7, Day 14, Day 30, Day 60, Day 90, Day 120|Colic, 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)., Day 7, Day 14, Day 30, Day 60, Day 90, Day 120|Gas/flatulence severity, 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)., Day 7, Day 14, Day 30, Day 60, Day 90, Day 120|Abdominal distension severity, 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)., Day 7, Day 14, Day 30, Day 60, Day 90, Day 120|GIGER score, 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., Day 7, Day 14, Day 60, Day 90, Day 120|Investigator's evaluation of the evolution of FGIDs, 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., Day 14, Day 30, Day 60, Day 90, Day 120|Number of bottles at night, The number of bottles at night will be recorded on average over the last 3 days., D7, D14, D30, D60, D90, D120|Sleep, 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)., Day 7, Day 14, Day 30, Day 60, Day 90, Day 120|Infant's quality of life, Parents will complete the QUALIN questionnaire (score from -68 to +68) (Manificat et al., 2000) over the last week., Day 7, Day 14, Day 30, Day 60, Day 90, Day 120|Weight, Weight will be expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards., Day 30, Day 60, Day 90, Day 120|Height, Height will be expressed in cm and in z scores according to the WHO Child Growth Standards., Day 30, Day 60, Day 90, Day 120|Head circumference, Head circumference will be expressed in cm and in z scores according to the WHO Child Growth Standards., Day 30, Day 60, Day 90, Day 120|BMI, BMI will be expressed in value and z scores according to the WHO Child Growth Standards., Day 30, Day 60, Day 90, Day 120|Adverse events, Any untoward medical reaction occuring from the signatture of the consent until the end of the participant's participation, Through study completion (up to 30 days or 120 days if participation to the optional intervention period)|Parents' satisfaction, 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., Day 7, Day 14, Day 30, Day 60, Day 90, Day 120