Trials / Completed

CompletedNCT06755424

GI Symptoms in Infants Fed Goat Milk-based Infant Formula

Goat Milk-based Infant Formula and the Prevalence of Gastrointestinal Symptoms in Infants: a Real-world-evidence Study from Brazil, Mexico, Russia, and the Netherlands

Status: Completed
Phase: —
Study type: Observational
Enrollment: 425 (actual)

Sponsor: Ausnutria Hyproca B.V. · Industry
Sex: All
Age: 0 Months – 24 Months
Healthy volunteers: Accepted

Summary

A cross-sectional observational survey was conducted in Brazil, Mexico, Russia, and The Netherlands by recruiting parents/legal guardians through social media. Gastrointestinal symptoms after introduction of Goat milk-based infant formula (GMF) were questioned using the validated Cow's Milk-Related Symptom Score (CoMiSS®; scoring 0-33), lower scores indicate fewer symptoms. Occurrence of crying, gassiness, eczema, respiratory symptoms and stool consistency were asked retrospectively before and ≥14 days after introduction of GMF.

Detailed description

A cross-sectional observational online anonymous survey on GI symptoms in infants aged 0-24 months fed GMF has been developed and conducted in Brazil, Mexico, Russia, and The Netherlands. The GMF of interest was commercially available Kabrita® stage 1 or 2 (Ausnutria, B.V., the Netherlands). Participants who had purchased Kabrita® were asked to complete a voluntary survey regarding their experience and observation on their infant's GI complaints. No inclusion criteria were set at the time point of sending out the survey. The survey consisted of 30 questions and was online from June 2021 until November 2022. The survey and associated data collection do not meet the criteria for human subject research and therefore approval by an institutional and/or licensing committee is not needed, and participant consent is not required. Participation in the survey was anonymized and completely voluntary.

Conditions

Timeline

Start date: 2022-06-01
Primary completion: 2022-11-01
Completion: 2022-11-30
First posted: 2025-01-01
Last updated: 2025-01-01

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT06755424. Inclusion in this directory is not an endorsement.