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

April 30, 2026 updated by: United Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
346

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of regurgitation
Time Frame: Day 14
Decrease of the daily number of regurgitation between baseline and day 14
Day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of regurgitations
Time Frame: Day 30, Day 90
Change in the daily number of regurgitation between baseline and day 30 / day 90
Day 30, Day 90
Severity of regurgitation episodes
Time Frame: Day 14, Day 30, Day 90
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
Time Frame: Day 14, Day 30, Day 90
Average daily stool's number
Day 14, Day 30, Day 90
Stools' consistency
Time Frame: Day 14, Day 30, Day 90
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
Time Frame: Day 14, Day 30, Day 90
Frequency : Occurence of diarrhea
Day 14, Day 30, Day 90
Severity of diarrhea
Time Frame: Day 14, Day 30, Day 90
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
Time Frame: Day 14, Day 30, Day 90
Occurence of constipation
Day 14, Day 30, Day 90
Severity of constipation
Time Frame: Day 14, Day 30, Day 90
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
Time Frame: Day 14, Day 30, Day 90
Crying time reported by parents in class (Min : Less than 10 min / Max : 3h or more)
Day 14, Day 30, Day 90
Feeding refusal
Time Frame: Day 14, Day 30, Day 90
Percentage of parents reporting feeding refusal by frequency of occurence (Never / Rarely / Sometimes / Often / Always)
Day 14, Day 30, Day 90
Abnormal posturing
Time Frame: Day 14, Day 30, Day 90
Percentage of parents reporting abnormal posturing by frequency of occurence (Never / Rarely / Sometimes / Often / Always)
Day 14, Day 30, Day 90
Sleep quality
Time Frame: Day 14, Day 30, Day 90
Percentage of parents reporting poor sleep quality (Excellent / Good / Fair / Poor)
Day 14, Day 30, Day 90
Anthropometric parameters - Weight
Time Frame: Day 14, Day 30, Day 90
Body weight measured in kilograms (kg)
Day 14, Day 30, Day 90
Anthropometric parameters - Length
Time Frame: Day 14, Day 30, Day 90
Body length measured in centimeters (cm)
Day 14, Day 30, Day 90
Anthropometric parameters - Head circumference
Time Frame: Day 14, Day 30, Day 90
Head circumference measured in centimeters (cm)
Day 14, Day 30, Day 90
Anthropometric parameters - BMI
Time Frame: Day 14, Day 30, Day 90
Body mass index calculated as kg/m²
Day 14, Day 30, Day 90
Anthropometric parameters - Weight-for-height z-score
Time Frame: Day 14, Day 30, Day 90
Weight-for-height z-score calculated according to WHO Child Growth Standards
Day 14, Day 30, Day 90
Use of drug treatments
Time Frame: Day 14, Day 30, Day 90
Frequency of use of proton-pump inhibitors, prokinetics, other GERD treatment
Day 14, Day 30, Day 90
Parents' satisfaction
Time Frame: Day 14, Day 30, Day 90
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
Time Frame: Day 14, Day 30, Day 90
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
United Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Statitec

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alexandra Papadopoulou, University of Athens, Athens Children's Hospital "AGIA SOFIA"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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