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

Gastroesophageal Reflux in Children Clinical Trial

— STELLAR  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04358146
• Other study ID #: UP2017-04-STELLAR
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2020
• Source: United Pharmaceuticals
• Contact: Bastian CUMINAL
• Phone: 0033155372222
• Email: b.cuminal[@]novalac.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 346
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux in Children

Intervention

Other:
• Experimental Infant formula
Exclusive formula feeding with the new infant formula thickened with fibers
• Infant formula thickened with locust bean gum
Exclusive formula feeding with the formula thickened with locust bean

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
United Pharmaceuticals	Statitec

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of regurgitation	Decrease of the daily number of regurgitation between baseline and day 14	Day 14