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

United Pharmaceuticals

Status: Unknown

Conditions: Gastroesophageal Reflux in Children

Treatments: Other: Experimental Infant formula; Other: Infant formula thickened with locust bean gum

Study type: Interventional

Funder types: Industry

Identifiers

NCT04358146

UP2017-04-STELLAR

Details and patient eligibility

About

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.

Full 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).

Enrollment: 346 estimated patients

Sex: All

Ages: 2 weeks to 4 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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346 participants in 2 patient groups

Test

Experimental group

Description:

new thickened infant formula containing fibres

Treatment:

Other: Experimental Infant formula

Control

Active Comparator group

Description:

infant formula thickened with locust bean

Treatment:

Other: Infant formula thickened with locust bean gum