Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs
NCT03513744 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340
Last updated 2023-10-16
Summary
The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.
Conditions
- Infant Nutrition
Interventions
- DIETARY_SUPPLEMENT
-
human milk oligosaccharides
mixture of five different human milk oligosaccharides
Sponsors & Collaborators
-
Analyze & Realize
collaborator NETWORK -
Jennewein Biotechnologie GmbH
lead INDUSTRY
Principal Investigators
-
Frank Jochum, Dr. med. · Universitaetsmedizin Berlin, Charité
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Day
- Max Age
- 13 Days
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-11-19
- Primary Completion
- 2021-03-03
- Completion
- 2021-04-05
Countries
- Germany
- Italy
- Spain
Study Locations
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