Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14 days
Maximum Age: 4 months
Healthy Volunteers: f
View:
• ≥ 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
Locations
Other Locations
Belgium
Center_14
ACTIVE_NOT_RECRUITING
Namur
Center_15
RECRUITING
Thuin
France
Center_09
ACTIVE_NOT_RECRUITING
Castelnau-le-lez
Center_02
RECRUITING
Étampes
Center_05
RECRUITING
Libourne
Centre_10
RECRUITING
Maromme
Center_16
RECRUITING
Nice
Center_08
RECRUITING
Vincennes
Greece
Center_01
RECRUITING
Athens
Center_11
RECRUITING
Thessaloniki
Italy
Center_12
RECRUITING
Naples
Center_13
RECRUITING
Naples
Contact Information
Primary
Magalie JEGAT
m.jegat@novalac.com
+330155372222
Backup
ANNE-SOPHIE GARREAU
as.garreau@novalac.com
Time Frame
Start Date: 2023-03-17
Estimated Completion Date: 2026-12-03
Participants
Target number of participants: 346
Treatments
Experimental: Test
new thickened infant formula containing fibres
Active_comparator: Control
infant formula thickened with locust bean
Related Therapeutic Areas
Sponsors
Leads: United Pharmaceuticals
Collaborators: Statitec