Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)

Not Applicable

• Conditions: Gastroesophageal Reflux in Children
• Interventions: Other: Experimental Infant formula; Other: Infant formula thickened with locust bean gum

• Registration Number: NCT04358146
• Lead Sponsor: United Pharmaceuticals

Brief Summary

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).

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Study Start: 2020-07-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 346

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Experimental Infant formula	new thickened infant formula containing fibres
Control	Infant formula thickened with locust bean gum	infant formula thickened with locust bean

Primary Outcome Measures

Name	Time	Method
Frequency of regurgitation	Day 14	Decrease of the daily number of regurgitation between baseline and day 14