NCT05340712

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

Evaluation of the Efficacy of a New Specific Infant Formula With a Prebiotic and Probiotics in Case of Functional Constipation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: United Pharmaceuticals · Industry
• Sex: All
• Age: 1 Month – 12 Months
• Healthy volunteers: Not accepted

Summary

This study aims to assess the clinical efficacy, safety and tolerance of a new formula containing a prebiotic and a mix of probiotics in the specific population of infants suffering from functional constipation through a superiority, double-blind, randomized, placebo-controlled trial.

Detailed description

The study comprises a selection period of 1 week where the eligibility of the infant to participate in the study will be evaluated. Once his/her participation is confirmed, the tested formula will be compared to a standard formula during a 2-month study period followed by an optional follow-up period of 2 months where only the tested formula will be used.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-20
• Primary completion: 2023-12-01
• Completion: 2024-09-01
• First posted: 2022-04-22
• Last updated: 2022-11-07

Locations

2 sites across 1 country: Italy