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Recruiting NCT06488274

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

No phase Interventional Functional Gastrointestinal Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: New infant formula.
Who it may be relevant to
Registry conditions: Functional Gastrointestinal Disorders. Basic parameters: up to 4 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Assessment of the Evolution of functIonal Gastrointestinal Disorders in Infants During Their Dietary Management With a New Infant Formula

Overview

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.

Interventions

  • Dietary supplement New infant formula
    The new formula will be given to infants during the 4-month study period.

Primary outcome measures

  • Change from baseline of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale score [Time frame: Day 30]
Secondary outcome measures (12)
  • Evolution of FGIDs (regurgitations, colic and constipation) [Time frame: Day 14, Day 30, Day 60, Day 90, Day 120]
  • Regurgitation frequency [Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120]
  • Regurgitation severity [Time frame: Day 14, Day 30, Day 60, Day 90, Day 120]
  • Stool frequency and consistency in non constipated infant [Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120]
  • Stool frequency and consistency in constipated infant [Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120]
  • Defecation pain frequency in constipated infant [Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120]
  • Colic [Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120]
  • Gas/flatulence severity [Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120]
  • Abdominal distension severity [Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120]
  • GIGER score [Time frame: Day 7, Day 14, Day 60, Day 90, Day 120]
  • Investigator's evaluation of the evolution of FGIDs [Time frame: Day 14, Day 30, Day 60, Day 90, Day 120]
  • Number of bottles at night [Time frame: D7, D14, D30, D60, D90, D120]

Eligibility criteria

Inclusion criteria

  • 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:

  • Infants born at 35 weeks or more of gestational age
  • Infants up to 4 months of age

Exclusion criteria

  • Exclusively or partially breastfed infants (i.e. \> 2 breast feeds per day) with maternal willingness to continue breastfeeding
  • Diversified infants or whose parents intend to start diversification within the first 2 weeks of the study
  • Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusion visit (V0)
  • The willingness to take additional pre-, probiotics or thickening agents during the study
  • Known allergy/intolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 4 centers
  • Site 02 — Nice
  • Site 04 — Paris
  • Site 03 — Toulon
  • Site 01 — Vincennes

Publications

  • 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. PMID 34350308
  • 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. PMID 8088297
  • 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: 10.109 PMID 30672767
  • 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. PMID 10911526

Identifiers

NCT: NCT06488274 · UP2022_FGID

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗