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Clinical Trials/NCT02425423
NCT02425423CompletedPhase 3

Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula

United Pharmaceuticals4 sites in 2 countries100 target enrollmentStarted: June 2013Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
100
Locations
4
Primary Endpoint
Number of episodes of regurgitation per day
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 5 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Aged ≤ 5 months old
  • •fully formula fed
  • •with at least 5 episodes of regurgitation per day

Exclusion Criteria

  • •Breast fed infants
  • •Infants presenting symptoms of a complicated gastroesophageal reflux
  • •Infants presenting intestinal disorders

Arms & Interventions

New thickened infant formula

Experimental

Intervention: New thickened formula (Dietary Supplement)

Outcomes

Primary Outcomes

Number of episodes of regurgitation per day

Time Frame: 14 days

Secondary Outcomes

  • Regurgitation score(3 months)
  • Growth parameters (Weight, height and head circumference)(3 months)
  • Digestive tolerance (stools' number and consistency)(3 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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