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Clinical Trials/NL-OMON21625
NL-OMON21625
Completed
Not Applicable

A randomised, controlled, double-blind trial to evaluate intestinal tolerance of a renewed anti-reflux formula in infants with regurgitation.

Danone Research – Centre for Specialised Nutrition0 sites98 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Danone Research – Centre for Specialised Nutrition
Enrollment
98
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

/A

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Danone Research – Centre for Specialised Nutrition

Eligibility Criteria

Inclusion Criteria

  • •1\. Healthy term infants (37\-42 weeks gestation at birth);
  • •2\. Age \<\= 3 months at screening;

Exclusion Criteria

  • •1\. Clinically significant congenital disease including gastroesophageal, respiratory, and neurological disorders, (suspicion of) food allergies, and disease affecting normal growth;
  • •2\. Gastrointestinal infection within 4 weeks prior to randomisation;

Outcomes

Primary Outcomes

Not specified

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