An observational study in Stool Assessment, Skin Rash and Urticaria, sponsored by Ausnutria Hyproca B.V.. Completed at 1 site in Netherlands. Open to participants aged 0 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-01.
Sponsored by Ausnutria Hyproca B.V. · Observational
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.
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.
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This study's enrollment of 425 is above the median of 71 across 18 observational studies indexed under Exanthema.
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infants aged 0-24 months
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Exclusion Criteria:
Intervention of interest commercially available Kabrita® stage 1 or 2 compared to any other infant formula type
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
Time frame: 14 days
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)
Time frame: 14 days
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Ausnutria Hyproca B.V.