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To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation

NCT04042454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2023-07-13

No results posted yet for this study

Summary

A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)

Conditions

Interventions

OTHER

milk based anti-regurgitation infant formula

Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.

OTHER

Milk based infant formula

Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.

Sponsors & Collaborators

  • Nutricia Research

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
9 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2023-05-23
Completion
2023-05-23

Countries

  • Italy
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

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 NCT04042454 on ClinicalTrials.gov