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

Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroesophageal Reflux in Children
• Intervention / Treatment: Other: Experimental Infant formula; Other: Infant formula thickened with locust bean gum

Detailed Description

The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional).

The 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).

• Study Type: Interventional
• Enrollment (Estimated): 346
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ANNE-SOPHIE GARREAU; Email: as.garreau@novalac.com
• Study Contact Backup: Name: Magalie JEGAT; Phone Number: +330155372222; Email: m.jegat@novalac.com

Study Locations

• Belgium
  • Namur, Belgium
    • Active, not recruiting
    • Center_14
  • Thuin, Belgium
    • Recruiting
    • Center_15
    • Contact: MD
• France
  • Castelnau-le-Lez, France
    • Active, not recruiting
    • Center_09
  • Libourne, France
    • Recruiting
    • Center_05
    • Contact: MD
  • Maromme, France
    • Recruiting
    • Centre_10
    • Contact: MD
  • Nice, France
    • Recruiting
    • Center_16
    • Contact: MD
  • Vincennes, France
    • Recruiting
    • Center_08
    • Contact: MD
  • Étampes, France
    • Recruiting
    • Center_02
    • Contact: MD
• Greece
  • Athens, Greece
    • Recruiting
    • Center_01
    • Contact: MD
  • Thessaloniki, Greece
    • Recruiting
    • Center_11
    • Contact: Ioanni, MD
• Italy
  • Naples, Italy
    • Recruiting
    • Center_12
    • Contact: MD
  • Naples, Italy
    • Recruiting
    • Center_13
    • Contact: MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 4 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; new thickened infant formula containing fibres	Other: Experimental Infant formula; Exclusive formula feeding with the new infant formula thickened with fibers
Active Comparator: Control; infant formula thickened with locust bean	Other: Infant formula thickened with locust bean gum; Exclusive formula feeding with the formula thickened with locust bean

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of regurgitation	Decrease of the daily number of regurgitation between baseline and day 14	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of regurgitations	Change in the daily number of regurgitation between baseline and day 30 / day 90	Day 30, Day 90
Severity of regurgitation episodes	Severity of regurgitations will be assessed using the adapted Vandenplas' score (range: 0 to 6; higher scores indicate more severe regurgitation)	Day 14, Day 30, Day 90
Stools' frequency	Average daily stool's number	Day 14, Day 30, Day 90
Stools' consistency	The Amsterdam Infant Stool Scale (AISS) (consistency categories: A [watery] to D [hard]; higher categories indicate firmer stools)	Day 14, Day 30, Day 90
Frequency of diarrhea	Frequency : Occurence of diarrhea	Day 14, Day 30, Day 90
Severity of diarrhea	Severity of diarrhea assessed using a study-specific score calculated as the sum of the products of each watery stool and its volume over 2 days (minimum score: 6; no upper limit; higher scores indicate more severe diarrhea)	Day 14, Day 30, Day 90
Frequency of constipation	Occurence of constipation	Day 14, Day 30, Day 90
Severity of constipation	Severity of constipation assessed using a study-specific score (range: 1 to 3; higher scores indicate more severe constipation)	Day 14, Day 30, Day 90
Crying time	Crying time reported by parents in class (Min : Less than 10 min / Max : 3h or more)	Day 14, Day 30, Day 90
Feeding refusal	Percentage of parents reporting feeding refusal by frequency of occurence (Never / Rarely / Sometimes / Often / Always)	Day 14, Day 30, Day 90
Abnormal posturing	Percentage of parents reporting abnormal posturing by frequency of occurence (Never / Rarely / Sometimes / Often / Always)	Day 14, Day 30, Day 90
Sleep quality	Percentage of parents reporting poor sleep quality (Excellent / Good / Fair / Poor)	Day 14, Day 30, Day 90
Anthropometric parameters - Weight	Body weight measured in kilograms (kg)	Day 14, Day 30, Day 90
Anthropometric parameters - Length	Body length measured in centimeters (cm)	Day 14, Day 30, Day 90
Anthropometric parameters - Head circumference	Head circumference measured in centimeters (cm)	Day 14, Day 30, Day 90
Anthropometric parameters - BMI	Body mass index calculated as kg/m²	Day 14, Day 30, Day 90
Anthropometric parameters - Weight-for-height z-score	Weight-for-height z-score calculated according to WHO Child Growth Standards	Day 14, Day 30, Day 90
Use of drug treatments	Frequency of use of proton-pump inhibitors, prokinetics, other GERD treatment	Day 14, Day 30, Day 90
Parents' satisfaction	Parental satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion)	Day 14, Day 30, Day 90
Investigator's satisfaction	Investigator satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion)	Day 14, Day 30, Day 90

Collaborators and Investigators

• Sponsor: United Pharmaceuticals
• Collaborators: Statitec
• Investigators: Study Director: Alexandra Papadopoulou, University of Athens, Athens Children's Hospital "AGIA SOFIA"

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): December 3, 2026

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Reflux
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux; Gastrointestinal Agents; Antidiarrheals; locust bean gum
• Other Study ID Numbers: UP2017-04-STELLAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No