Status:
UNKNOWN
Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
Ausnutria Hyproca B.V.
Conditions:
Infant Nutrition Disorders
Gastrointestinal Diseases
Eligibility:
All Genders
14-90 years
Phase:
NA
Brief Summary
In this trial, the investigators aim to assess impact of goat milk-based infant formula on the severity and frequency of gastrointestinal symptoms, as well as other associated symptoms, and the health...
Detailed Description
Gastrointestinal symptoms are frequent in the first 6 months of life in otherwise healthy infants fed cow milk-based infant formulas (CMF). In management special infant formulas may be considered, alt...
Eligibility Criteria
Inclusion
- Healthy term infants with a gestational age between 37 and 42 weeks.
- Infants who have received cow's milk infant formula for at least 7 consecutive days.
- Exclusive formula feeding.
- Cow's Milk-related Symptoms Score (CoMiSS) value at baseline between ≥6 and \<10.
Exclusion
- exclusive or partial breastfeeding (or feeding human milk)
- introduced to solid food/supplementary feeding
- any congenital or chronic condition
- previous or present gastrointestinal illness or malformation that could interfere with study parameters
- diagnosed cow's milk allergy
- receiving medication with regard to functional gastrointestinal disorders (i.e., reflux medication)
- sibling already participating in this study, and/or participating in another clinical trial.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT06108401
Start Date
November 1 2023
End Date
December 31 2025
Last Update
October 31 2023
Active Locations (1)
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1
Department of Paediatrics, The Medical University of Warsaw, Poland
Warsaw, Poland, 01-183