Clinical trial NCT06488274: Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
Official title: Assessment of the Evolution of functIonal Gastrointestinal Disorders in Infants During Their Dietary Management With a New Infant Formula
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Keywords: Regurgitations
Colic
Constipation
Infant formula
GIGER scale
Nutrition
Infants
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Axiodis CRO
First posted: 2024-07-05
Enrollment: 139
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional, open-label, non-comparative multicenter study
Primary purpose: OTHER

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.

Eligibility criteria: 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;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)

Primary outcomes:
measure: Change from baseline of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale score
timeFrame: Day 30
Secondary outcomes:
measure: Evolution of FGIDs (regurgitations, colic and constipation)
timeFrame: Day 14, Day 30, Day 60, Day 90, Day 120
measure: Regurgitation frequency
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
measure: Regurgitation severity
timeFrame: Day 14, Day 30, Day 60, Day 90, Day 120
measure: Stool frequency and consistency in non constipated infant
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
measure: Stool frequency and consistency in constipated infant
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
measure: Defecation pain frequency in constipated infant
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
measure: Colic
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
measure: Gas/flatulence severity
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
measure: Abdominal distension severity
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
measure: GIGER score
timeFrame: Day 7, Day 14, Day 60, Day 90, Day 120
measure: Investigator's evaluation of the evolution of FGIDs
timeFrame: Day 14, Day 30, Day 60, Day 90, Day 120
measure: Number of bottles at night
timeFrame: D7, D14, D30, D60, D90, D120
measure: Sleep
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
measure: Infant's quality of life
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
measure: Weight
timeFrame: Day 30, Day 60, Day 90, Day 120
measure: Height
timeFrame: Day 30, Day 60, Day 90, Day 120
measure: Head circumference
timeFrame: Day 30, Day 60, Day 90, Day 120
measure: BMI
timeFrame: Day 30, Day 60, Day 90, Day 120
measure: Adverse events
timeFrame: Through study completion (up to 30 days or 120 days if participation to the optional intervention period)
measure: Parents' satisfaction
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Other outcomes:
Locations:
city: Nice
country: France
facility: Site 02
city: Paris
country: France
facility: Site 04
city: Toulon
country: France
facility: Site 03
city: Vincennes
country: France
facility: Site 01
Study officials:
affiliation: Ambulatory pediatrician in Vincennes (France)
name: Christophe Batard, Dr.
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Intercommunal (CHI) in Créteil (France)
name: Camille Jung, Prof.
role: STUDY_CHAIR
References:
citation: Pados BF, Repsha C, Hill RR. The Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers. Glob Pediatr Health. 2021 Jul 14;8:2333794X211033130. doi: 10.1177/2333794X211033130. eCollection 2021.
citation: Vandenplas Y, Hachimi-Idrissi S, Casteels A, Mahler T, Loeb H. A clinical trial with an "anti-regurgitation" formula. Eur J Pediatr. 1994 Jun;153(6):419-23. doi: 10.1007/BF01983405.
citation: Huysentruyt K, Koppen I, Benninga M, Cattaert T, Cheng J, De Geyter C, Faure C, Gottrand F, Hegar B, Hojsak I, Miqdady M, Osatakul S, Ribes-Koninckx C, Salvatore S, Saps M, Shamir R, Staiano A, Szajewska H, Vieira M, Vandenplas Y; BITSS working group. The Brussels Infant and Toddler Stool Scale: A Study on Interobserver Reliability. J Pediatr Gastroenterol Nutr. 2019 Feb;68(2):207-213. doi: 10.1097/MPG.0000000000002153.
citation: Manificat S, Dazord A, Langue J, Danjou G, Bauche P, Bovet F, Cubells J, Luchelli R, Tockert E, Conway K. [Evaluation of the quality of life of infants and very young children: validation of a questionnaire. Multicenter European study]. Arch Pediatr. 2000 Jun;7(6):605-14. doi: 10.1016/s0929-693x(00)80127-x. French.