Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
NCT ID: NCT04358146
Last Updated: 2020-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
346 participants
INTERVENTIONAL
2020-07-01
2022-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula
NCT03371615
To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation
NCT04042454
A Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted After Choking Spell
NCT03130543
Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
NCT01956682
Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
NCT04013087
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test
new thickened infant formula containing fibres
Experimental Infant formula
Exclusive formula feeding with the new infant formula thickened with fibers
Control
infant formula thickened with locust bean
Infant formula thickened with locust bean gum
Exclusive formula feeding with the formula thickened with locust bean
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Experimental Infant formula
Exclusive formula feeding with the new infant formula thickened with fibers
Infant formula thickened with locust bean gum
Exclusive formula feeding with the formula thickened with locust bean
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* exclusive or predominant formula feeding
* whose parents signed informed consent
Exclusion Criteria
* 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
2 Weeks
4 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Statitec
INDUSTRY
United Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexandra Papadopoulou
Role: STUDY_DIRECTOR
University of Athens, Athens Children's Hospital "AGIA SOFIA"
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UP2017-04-STELLAR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.