GI Symptoms in Infants Fed Goat Milk-based Infant Formula

NCT06755424 | Completed

• 1 other identifier: P21-013
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

gastrointestinal symptoms; CoMiSS; consumer survey; goat milk-based infant formula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• retrospective assessment GI symptoms before introduction of Kabrita® and improvement minimally 14 days after introduction.

  14 days

Study Arms (1)

GMF-consumers and GMF-non-consumers

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

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

infants aged 0-24 months

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ausnutria Hyproca B.V.: lead

Study Sites (1)

Ausnutria B.V

Zwolle, Overijssel, 8025BM, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39935845 DERIVED

MeSH Terms

Conditions

Exanthema; Urticaria; Gastroesophageal Reflux; Diarrhea, Infantile; Constipation

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 14 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 1, 2025
• Study Start: June 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 30, 2022
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)