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

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.

Study Overview

• Status: Completed
• Conditions: Constipation; Urticaria; Skin Rash; Regurgitation; Bloating; Stool Assessment; Crying Time in Colicky Infants; Respiratory Ilness; DIARRHEA, INFANTILE

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.

• Study Type: Observational
• Enrollment (Actual): 425

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025BM
      • Ausnutria B.V

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

infants aged 0-24 months

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
GMF-consumers and GMF-non-consumers; Intervention of interest commercially available Kabrita® stage 1 or 2 compared to any other infant formula type

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GI symptoms as assessed by the Cow's Milk-Related Symptom Score (CoMiSS®) after introduction of GMF	Cow's Milk-Related Symptom Score (CoMiSS®; scoring 0-33), lower scores indicate fewer symptoms. The CoMiSS® was developed by an expert panel to increase the awareness of health care professionals for the presence and severity of symptoms, which might be related to cow's milk protein intake. The CoMiSS® is a validated and easy-to-use clinical tool with an estimated sensitivity between 20-77% and a specificity of 54-92% to suspected cow's milk allergy. The CoMiSS® assesses the stool pattern using the Bristol Scale (hard stools, normal stools, soft stools, liquid stools, watery stools); skin symptoms of atopic eczema on head, neck and/or trunk as well as on arms, hands and/or feet; skin symptoms of urticaria; respiratory symptoms, regurgitation; and crying without any obvious cause in hours per day. The total score ranges from 0-33, where lower scores indicate less severe symptoms	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retrospective assessment GI symptoms before introduction of Kabrita® and improvement minimally 14 days after introduction.	The survey inquired about GI symptoms before and after introduction of GMF (no score on a scale). These symptoms included gassiness (specified as burping, passing gas, bloating, abdominal pain and/or colic); skin symptoms (specified as rashes, and/or eczema); watery stools/diarrhoea; hard stools/constipation; crying without any obvious cause. Questions before switching to GMF: minor GI complaints (y/n). If yes, which complaints (choices: Gassiness / Skin symptoms / Watery stools/diarrhoea / Hard stools/constipation / None). Tendency to cry without any obvious cause (y/n) Questions after switching to GMF: experienced less complaints (y/n). If yes, which complaints improved (choices: Gassiness / Skin symptoms / Watery stools/diarrhoea / Hard stools/constipation / None of the above). Tendency to cry without any obvious cause (choices: Yes, similar as before / Yes, less than before / Yes, worse than before / No). Crying: on average each day (choices: <1, 1-1.5, 1.5-2, 2-3, 3-4, 4-5, >5h)	14 days

Collaborators and Investigators

• Sponsor: Ausnutria Hyproca B.V.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: gastrointestinal symptoms; goat milk-based infant formula; CoMiSS; consumer survey
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Vascular; Constipation; Diarrhea; Urticaria; Exanthema; Diarrhea, Infantile
• Other Study ID Numbers: P21-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No