Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental Infant formula, Infant formula thickened with locust bean gum.
- Who it may be relevant to
- Registry conditions: Gastroesophageal Reflux in Children. Basic parameters: 2 Weeks — 4 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, France, Greece, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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).
Interventions
- Other Experimental Infant formula
Exclusive formula feeding with the new infant formula thickened with fibers - Other Infant formula thickened with locust bean gum
Exclusive formula feeding with the formula thickened with locust bean
Primary outcome measures
- Frequency of regurgitation [Time frame: Day 14]
Secondary outcome measures (12)
- Frequency of regurgitations [Time frame: Day 30, Day 90]
- Severity of regurgitation episodes [Time frame: Day 14, Day 30, Day 90]
- Stools' frequency [Time frame: Day 14, Day 30, Day 90]
- Stools' consistency [Time frame: Day 14, Day 30, Day 90]
- Frequency of diarrhea [Time frame: Day 14, Day 30, Day 90]
- Severity of diarrhea [Time frame: Day 14, Day 30, Day 90]
- Frequency of constipation [Time frame: Day 14, Day 30, Day 90]
- Severity of constipation [Time frame: Day 14, Day 30, Day 90]
- Crying time [Time frame: Day 14, Day 30, Day 90]
- Feeding refusal [Time frame: Day 14, Day 30, Day 90]
- Abnormal posturing [Time frame: Day 14, Day 30, Day 90]
- Sleep quality [Time frame: Day 14, Day 30, Day 90]
Eligibility criteria
Inclusion criteria
- ≥ 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
France · 6 centers
- Center_09 — Castelnau-le-Lez
- Center_02 — Étampes
- Center_05 — Libourne
- Centre_10 — Maromme
- Center_16 — Nice
- Center_08 — Vincennes
Belgium · 2 centers
- Center_14 — Namur
- Center_15 — Thuin
Greece · 2 centers
- Center_01 — Athens
- Center_11 — Thessaloniki
Italy · 2 centers
- Center_12 — Naples
- Center_13 — Naples
Identifiers
NCT: NCT04358146 · UP2017-04-STELLAR