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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Center_15
  Thuin, Belgium 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

Study contacts

• Study coordinator: Magalie JEGAT
• Email: m.jegat@novalac.com
• Phone: +330155372222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.