Trial | NCT04358146  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    346
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.
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 Started
Jul 01
2020
Anticipated
Primary Completion
Jan 01
2022
Anticipated
Study Completion
Mar 01
2022
Anticipated
Last Update
Apr 24
2020

Other Experimental Infant formula

Exclusive formula feeding with the new infant formula thickened with fibers

Other Infant formula thickened with locust bean gum

Exclusive formula feeding with the formula thickened with locust bean

Test Experimental

new thickened infant formula containing fibres

Control Active Comparator

infant formula thickened with locust bean

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
No Results Posted