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Tests treatment safety and results for Gastroesophageal Reflux in Children
Official title Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
ClinicalTrials.gov ID: NCT04358146
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 4
You may be able to join 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 likely can't join 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...
- Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk...
The study team makes the final eligibility decision.
Where it's taking place
- Namur, Belgium
- Thuin, Belgium
- Castelnau-le-Lez, France
- Étampes, France
- Libourne, France
- Maromme, France
- Nice, France
- Vincennes, France
- Athens, Greece
- Thessaloniki, Greece
- Naples, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 weeks to 4 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Namur, Belgium; Thuin, Belgium; Castelnau-le-Lez, France; Étampes, France; Libourne, France; Maromme, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.