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

NCT06488274 | Recruiting

• 1 other identifier: UP2022_FGID
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 4

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.

Conditions

Functional Gastrointestinal Disorders

Keywords

Regurgitations; Colic; Constipation; Infant formula; GIGER scale; Nutrition; Infants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Evolution of FGIDs (regurgitations, colic and constipation)

  Day 14, Day 30, Day 60, Day 90, Day 120

• Regurgitation frequency

  Day 7, Day 14, Day 30, Day 60, Day 90, Day 120

• Regurgitation severity

  Day 14, Day 30, Day 60, Day 90, Day 120

• Stool frequency and consistency in non constipated infant

  Day 7, Day 14, Day 30, Day 60, Day 90, Day 120

• Stool frequency and consistency in constipated infant

  Day 7, Day 14, Day 30, Day 60, Day 90, Day 120

Study Arms (1)

Test formula

EXPERIMENTAL

The test product is a thickened infant formula containing symbiotic (fibers and probiotics)

Dietary Supplement: New infant formula

Interventions

New infant formula DIETARY_SUPPLEMENT

The new formula will be given to infants during the 4-month study period.

Test formula

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants presenting with at least one of the FGIDs below, defined based on adapted Rome IV criteria as follows:
• Regurgitations: 1.2 Colic: 1.3 Constipation:
• Infants born at 35 weeks or more of gestational age
• Infants up to 4 months of age

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• United Pharmaceuticals: lead
• Axiodis CRO: collaborator

Study Sites (4)

Site 02

Nice, France

NOT YET RECRUITING

Site 04

Paris, France

NOT YET RECRUITING

Site 03

Toulon, France

RECRUITING

Site 01

Vincennes, France

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 30672767 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases; Gastroesophageal Reflux; Colic; Constipation

Condition Hierarchy (Ancestors)

Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christophe Batard, Dr.

  Ambulatory pediatrician in Vincennes (France)

  STUDY DIRECTOR

• Camille Jung, Prof.

  Centre Hospitalier Intercommunal (CHI) in Créteil (France)

  STUDY CHAIR

Central Study Contacts

Anne-Sophie Garreau

CONTACT

0033-155372222; as.garreau@novalac.com

Caroline Thevret, Dr.

CONTACT

0033-155372222; c.thevret@novalac.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional, open-label, non-comparative multicenter study

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 5, 2024
• Study Start: October 21, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)