Actively Recruiting
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Led by United Pharmaceuticals · Updated on 2026-05-04
346
Participants Needed
12
Research Sites
193 weeks
Total Duration
On this page
Sponsors
U
United Pharmaceuticals
Lead Sponsor
S
Statitec
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 2 regurgitation episodes per day during the last 2 weeks and at least 4 episodes per day on average during the last 2 days
- Exclusive or predominant formula feeding
- Parents have signed informed consent
You will not qualify if you...
- Preterm infants or birth weight less than 2500 grams
- Post enteritis lactose intolerance
- Suspected or diagnosed cow's milk protein allergy requiring an eviction diet
- Use of medications affecting regurgitation or gastrointestinal transit (e.g., alginates, laxatives, antibiotics) unless stopped at least 7 days before inclusion
- Any condition that may interfere with participation or pose a particular risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Center_14
Namur, Belgium
Active, Not Recruiting
2
Center_15
Thuin, Belgium
Actively Recruiting
3
Center_09
Castelnau-le-Lez, France
Active, Not Recruiting
4
Center_02
Étampes, France
Actively Recruiting
5
Center_05
Libourne, France
Actively Recruiting
6
Centre_10
Maromme, France
Actively Recruiting
7
Center_16
Nice, France
Actively Recruiting
8
Center_08
Vincennes, France
Actively Recruiting
9
Center_01
Athens, Greece
Actively Recruiting
10
Center_11
Thessaloniki, Greece
Actively Recruiting
11
Center_12
Naples, Italy
Actively Recruiting
12
Center_13
Naples, Italy
Actively Recruiting
Research Team
M
Magalie JEGAT
CONTACT
A
ANNE-SOPHIE GARREAU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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