Gastroesophageal Reflux in ChildrenSTELLARNCT04358146
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
A study testing Experimental Infant formula and Infant formula thickened with locust bean gum in people with Gastroesophageal Reflux in Children, run by United Pharmaceuticals at 12 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 weeks to 4 months
- Conditions the study is for
- Gastroesophageal Reflux in Children
- What is being tested?
- Experimental Infant formula and Infant formula thickened with locust bean gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 17 Mar 2023to 3 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
ANNE-SOPHIE GARREAU contact
12 sites in 4 countries
France6 sites, 5 recruiting
- Active, not recruiting
Center_09
Castelnau-le-Lez
- Recruiting
Center_02
Étampes
MD
- Recruiting
Center_05
Libourne
MD
- Recruiting
Centre_10
Maromme
MD
- Recruiting
Center_16
Nice
MD
- Recruiting
Center_08
Vincennes
MD
Belgium2 sites, 1 recruiting
- Active, not recruiting
Center_14
Namur
- Recruiting
Center_15
Thuin
MD
Greece2 sites, 2 recruiting
- Recruiting
Center_01
Athens
MD
- Recruiting
Center_11
Thessaloniki
Ioanni, MD
Italy2 sites, 2 recruiting
- Recruiting
Center_12
Naples
MD
- Recruiting
Center_13
Naples
MD
About this study
Official title: 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.
Read the 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).
- Conditions
- Gastroesophageal Reflux in Children
- Being tested
- Experimental Infant formula, Infant formula thickened with locust bean gum
- Keywords
- Reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Infant formulaOther
Exclusive formula feeding with the new infant formula thickened with fibers
Infant formula thickened with locust bean gumOther
Exclusive formula feeding with the formula thickened with locust bean
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | new thickened infant formula containing fibres Receives: Other: Experimental Infant formula |
| Control | Active comparator | infant formula thickened with locust bean Receives: Other: Infant formula thickened with locust bean gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of regurgitation
Decrease of the daily number of regurgitation between baseline and day 14
Measured: Day 14
Secondary outcomes (20)
Frequency of regurgitations
Change in the daily number of regurgitation between baseline and day 30 / day 90
Measured: 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)
Measured: Day 14, Day 30, Day 90
Stools' frequency
Average daily stool's number
Measured: 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)
Measured: Day 14, Day 30, Day 90
Frequency of diarrhea
Frequency : Occurence of diarrhea
Measured: 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)
Measured: Day 14, Day 30, Day 90
Frequency of constipation
Occurence of constipation
Measured: 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)
Measured: Day 14, Day 30, Day 90
Crying time
Crying time reported by parents in class (Min : Less than 10 min / Max : 3h or more)
Measured: Day 14, Day 30, Day 90
Feeding refusal
Percentage of parents reporting feeding refusal by frequency of occurence (Never / Rarely / Sometimes / Often / Always)
Measured: Day 14, Day 30, Day 90
Abnormal posturing
Percentage of parents reporting abnormal posturing by frequency of occurence (Never / Rarely / Sometimes / Often / Always)
Measured: Day 14, Day 30, Day 90
Sleep quality
Percentage of parents reporting poor sleep quality (Excellent / Good / Fair / Poor)
Measured: Day 14, Day 30, Day 90
Anthropometric parameters - Weight
Body weight measured in kilograms (kg)
Measured: Day 14, Day 30, Day 90
Anthropometric parameters - Length
Body length measured in centimeters (cm)
Measured: Day 14, Day 30, Day 90
Anthropometric parameters - Head circumference
Head circumference measured in centimeters (cm)
Measured: Day 14, Day 30, Day 90
Anthropometric parameters - BMI
Body mass index calculated as kg/m²
Measured: 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
Measured: Day 14, Day 30, Day 90
Use of drug treatments
Frequency of use of proton-pump inhibitors, prokinetics, other GERD treatment
Measured: 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)
Measured: 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)
Measured: Day 14, Day 30, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start17 Mar 2023
- Primary completion3 Dec 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Statitec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358146
- Sponsor's protocol ID
- UP2017-04-STELLAR
- Acronym
- STELLAR
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2020
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No