GI Symptoms in Infants Fed Goat Milk-based Infant Formula

NCT ID: NCT06755424

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 425 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-11-30

Brief 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

Stool Assessment; Skin Rash; Urticaria; Regurgitation; Respiratory Ilness; Crying Time in Colicky Infants; Bloating; DIARRHEA, INFANTILE; Constipation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

GMF-consumers and GMF-non-consumers

Intervention of interest commercially available Kabrita® stage 1 or 2 compared to any other infant formula type

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• infants aged 0-24 months
• fed at least once with goat milk-based infants formula

Exclusion Criteria

• infants aged >24 months
• taking medication for functional GI disorders

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ausnutria Hyproca B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ausnutria B.V

Zwolle, Overijssel, Netherlands

Countries

Netherlands

References

Knipping K, Bohme J, Goossens D, van Lee L, van der Zee L. 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. Health Sci Rep. 2025 Feb 10;8(2):e70448. doi: 10.1002/hsr2.70448. eCollection 2025 Feb.

Reference Type: DERIVED

PMID: 39935845 (View on PubMed)

Other Identifiers

P21-013

Identifier Type: -

Identifier Source: org_study_id