Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Recruiting now · Not applicable
Conditions studied: Gastroesophageal Reflux in Children
In brief
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.
Key facts
- Study ID
- NCT04358146
- Run by
- United Pharmaceuticals
- People needed
- 346
- Starts
- 2023-03-17
- Expected to finish
- 2026-12-03
- Last updated by the study team
- 2026-05-04
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- Center_13 — Naples, Italy (enrolling)
- Center_15 — Thuin, Belgium (enrolling)
- Center_11 — Thessaloniki, Greece (enrolling)
- Center_12 — Naples, Italy (enrolling)
- Center_02 — Étampes, France (enrolling)
- Center_05 — Libourne, France (enrolling)
- Centre_10 — Maromme, France (enrolling)
- Center_16 — Nice, France (enrolling)
- Center_08 — Vincennes, France (enrolling)
- Center_01 — Athens, Greece (enrolling)
- Center_09 — Castelnau-le-Lez, France
- Center_14 — Namur, Belgium
Full record on ClinicalTrials.gov
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