Ireland
--:--IST
Recruiting Not applicable

Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)

NCT04358146 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2023-03-17
Last updated
2026-05-04

Condition(s) studied

Gastroesophageal Reflux in Children

Investigational drug(s) / intervention(s)

Experimental Infant formulaInfant formula thickened with locust bean gum

Experimental Infant formula: Exclusive formula feeding with the new infant formula thickened with fibers

Infant formula thickened with locust bean gum: Exclusive formula feeding with the formula thickened with locust bean

Study summary

The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.

Eligibility

Sex
ALL
Min age
2 Weeks
Max age
4 Months
Healthy volunteers
No
Inclusion Criteria: * ≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days, * exclusive or predominant formula feeding * whose parents signed informed consent Exclusion Criteria: * preterm infants or birthweight \<2500g * Post enteritis lactose intolerance * Suspected or diagnosed cow's milk protein allergy requiring an eviction diet * Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1) * Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject

Primary outcome measure(s)

  • Frequency of regurgitation — Day 14
    Decrease of the daily number of regurgitation between baseline and day 14

Trial sites (12)

FacilityCityRegionStatus
Center_14 Namur Belgium Active Not Recruiting
Center_15 Thuin Belgium Recruiting
Center_09 Castelnau-le-Lez France Active Not Recruiting
Center_02 Étampes France Recruiting
Center_05 Libourne France Recruiting
Centre_10 Maromme France Recruiting
Center_16 Nice France Recruiting
Center_08 Vincennes France Recruiting
Center_01 Athens Greece Recruiting
Center_11 Thessaloniki Greece Recruiting
Center_12 Naples Italy Recruiting
Center_13 Naples Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04358146 on ClinicalTrials.gov ↗ ← All trials in Italy