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

NCT05340712 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-11-07

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Delta Consultants

    collaborator UNKNOWN

  • United Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Annamaria Staiano, Prof. · Federico II University

  • Marc Benninga, Prof. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Caterina Strisciuglio, Prof. · University of Campania Luigi Vanvitelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2023-12-31
Completion
2024-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05340712 on ClinicalTrials.gov