GI Symptoms in Infants Fed Goat Milk-based Infant Formula

Ausnutria Hyproca

Status

Completed

Conditions

Crying Time in Colicky Infants

Bloating

Respiratory Ilness

Skin Rash

Regurgitation

Urticaria

Constipation

Stool Assessment

DIARRHEA, INFANTILE

Study type

Observational

Funder types

Industry

Identifiers

NCT06755424

P21-013

Details and patient eligibility

About

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.

Full 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.

Enrollment

425 patients

Sex

All

Ages

Under 24 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria