Evaluation of the Efficacy of a New Specific Infant Formula in Case of Functional Constipation

NAUnknownINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

July 20, 2022

Primary Completion Date

December 31, 2023

Study Completion Date

September 30, 2024

Conditions
Functional Constipation
Interventions
DIETARY_SUPPLEMENT

new infant formula

New formula containing a prebiotic and a mix of probiotics, randomly assigned to infants during a 2-month period and allocated to all infants during the optional open-label follow-up period of 2 months.

DIETARY_SUPPLEMENT

Standard formula

Standard infant formula containing no prebiotic nor probiotic, randomly assigned to infants during a 2-month period followed by an optional open-label follow-up period of 2 months with the new infant formula

Trial Locations (2)

80131

RECRUITING

"University of Naples Federico II", Napoli

80138

NOT_YET_RECRUITING

University of Campania Luigi Vanvitelli, Napoli

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Delta Consultants

UNKNOWN

lead

United Pharmaceuticals

INDUSTRY