New anti-regurgitation infant formula (STELLAR) for babies with reflux

Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial

This trial will test whether a new thickened infant formula reduces regurgitation in formula-fed babies with gastroesophageal reflux.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 346 (estimated)
• Ages: 2 Weeks to 4 Months
• Sex: All
• Sponsor: United Pharmaceuticals (Industry-sponsored)
• Locations: 12 sites (Namur and 11 other locations)
• Trial ID: NCT04358146 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, controlled comparison of a new anti-regurgitation formula versus a comparator formula thickened with locust bean gum in formula-fed infants with reflux. After a two-day pre-selection period, eligible infants are randomized and followed for one month, with an optional additional two-month follow-up. The primary measure is change in regurgitation frequency and secondary measures include digestive tolerance. Standard exclusion criteria apply, including prematurity, low birthweight, cow's milk protein allergy, and recent use of medications that affect gastrointestinal transit.

Who should consider this trial

Good fit: Formula-fed infants who have at least 2 regurgitations per day over the last two weeks and an average of at least 4 per day in the last two days, whose parents consent, and who meet the other inclusion criteria are eligible.

Not a fit: Preterm or low-birthweight infants, babies with suspected cow's milk protein allergy or post-enteritis lactose intolerance, and infants on interfering medications are unlikely to benefit from this formula in the study.

Why it matters

Potential benefit: If successful, the formula could reduce the number of regurgitation episodes and improve feeding comfort for affected infants.

How similar studies have performed: Other trials of thickened formulas, including those using locust bean gum, have shown reductions in regurgitation, so this approach has prior supporting evidence.

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

Where this trial is running

Namur and 11 other locations

• Center_14 — Namur, Belgium (Active_not_recruiting)
• Center_15 — Thuin, Belgium (Recruiting)
• Center_09 — Castelnau-le-Lez, France (Active_not_recruiting)
• Center_02 — Étampes, France (Recruiting)
• Center_05 — Libourne, France (Recruiting)
• Centre_10 — Maromme, France (Recruiting)
• Center_16 — Nice, France (Recruiting)
• Center_08 — Vincennes, France (Recruiting)
• Center_01 — Athens, Greece (Recruiting)
• Center_11 — Thessaloniki, Greece (Recruiting)
• Center_12 — Naples, Italy (Recruiting)
• Center_13 — Naples, Italy (Recruiting)

Study contacts

• Study coordinator: Magalie JEGAT

Conditions Gastroesophageal Reflux in Children; Reflux