GI Symptoms in Infants Fed Goat Milk-based Infant Formula

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.

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Key information

Conditions

Stool Assessment Bloating Constipation Crying Time in Colicky Infants Deglutition Disorders Diarrhea Diarrhea, Infantile Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Exanthema Gastroesophageal Reflux Gastrointestinal Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Regurgitation Respiratory Ilness Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin Diseases, Vascular Skin Rash Skin and Connective Tissue Diseases Urticaria

Age range

0 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Ausnutria B.V

Zwolle, Overijssel, 8025BM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

GI symptoms as assessed by the Cow's Milk-Related Symptom Score (CoMiSS®) after introduction of GMF

Time frame: 14 days

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

Secondary outcomes

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

Time frame: 14 days

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)

Sponsors and collaborators

Lead sponsor

Ausnutria Hyproca B.V.

Industry

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jan 1, 2025
Registry last updated: Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed