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.
The study comprises a first period of 30 days followed by an optional intervention period of 90 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
139
The new formula will be given to infants during the 4-month study period.
Site 02
Nice, France
NOT_YET_RECRUITINGSite 04
Paris, France
NOT_YET_RECRUITINGSite 03
Toulon, France
RECRUITINGSite 01
Vincennes, France
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.
Time frame: Day 30
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.
Time frame: 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 \[Never; Rarely; Often; Always\].
Time frame: 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.
Time frame: 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).
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Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120