Stool AssessmentNCT06755424
GI Symptoms in Infants Fed Goat Milk-based Infant Formula
An observational study of Stool Assessment and Skin Rash, run by Ausnutria Hyproca B.V. at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Stool Assessment, Skin Rash, Urticaria
- How many people
- 425 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2022to 30 Nov 2022
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: infants aged 0-24 months
Who may be able to join
- infants aged 0-24 months
- fed at least once with goat milk-based infants formula
Who cannot join
- infants aged >24 months
- taking medication for functional GI disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Keywords
- gastrointestinal symptoms, CoMiSS, consumer survey, goat milk-based infant formula
- Medical subject headings
- Exanthema, Urticaria, Gastroesophageal Reflux, Diarrhea, Infantile, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (1)
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)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jun 2022
- Primary completion1 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stool AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 425 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Ausnutria Hyproca B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755424
- Sponsor's protocol ID
- P21-013
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39935845
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06755424
- Acronym / sponsor ID
- P21-013
- Conditions
- Stool Assessment, Skin Rash, Urticaria, Regurgitation, Respiratory Ilness, Crying Time in Colicky Infants
- Keywords
- gastrointestinal symptoms, CoMiSS, consumer survey, goat milk-based infant formula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Ausnutria Hyproca B.V.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GMF-consumers and GMF-non-consumers | – | –Intervention of interest commercially available Kabrita® stage 1 or 2 compared to any other infant formula type |
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infants aged 0-24 months
Key inclusion criteria (2 listed)
- infants aged 0-24 months
- fed at least once with goat milk-based infants formula
Key exclusion criteria (2 listed)
- infants aged >24 months
- taking medication for functional GI disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
retrospective assessment GI symptoms before introduction of Kabrita® and improvement minimally 14 days after introduction.
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Derived from this study: PubMed 39935845Knipping 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stool Assessment and Skin Rash, run by Ausnutria Hyproca B.V. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI symptoms as assessed by the Cow's Milk-Related Symptom Score (CoMiSS®) after introduction of GMF (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06755424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.