Gastrointestinal DiseasesNCT06301139
Goat Milk Infant Formula Comfort Study
A study testing Goat milk-based infant formula and Cow's milk-based infant formula with probiotic drops in people with Gastrointestinal Diseases and Cow's Milk Intolerance, run by Ausnutria Hyproca B.V. at 1 site in Spain.
Trial summary
In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops. Read more about this study
- Who is it for?
- Ages 6 weeks to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases, Cow's Milk Intolerance
- What is being tested?
- Goat milk-based infant formula and Cow's milk-based infant formula with probiotic drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2019to 1 Feb 2024
- Phase
- Interventional
- 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 6 weeks to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy full-term infant with birth weight ≥2,500 to ≤4,500 g
- Infant aged between 4 weeks and 3 months at enrolment
- CoMiSS value at baseline between 6 and 12
- Infant is exclusively bottle fed with cow's milk based infant formula at baseline
Who cannot join
- Breastfed infants
- Congenital illness or malformation that may affect infant feeding or normal growth
- Gastrointestinal disorders
- Confirmed cow or goat milk protein allergy or lactose intolerance
- Supplemental feeding
- Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrolment
- Infant participating in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Assess Improvement of Digestive Symptoms With Goat's Milk Infant Formula.
In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops.
Read the detailed description
Anecdotal evidence shows that the use of goat milk-based infant formula decreases discomfort of infants with cow's milk related symptoms. In this randomized controlled pilot study, the effect on comfort during usage of goat-milk based infant formula is studied. Twenty formula fed infants (aged between 6 weeks and 3 months) who experience mild discomfort will receive goat milk-based infant formula (GMF) or cow's mik based infant formula supplemented with probiotics lactobacillus reuteri drops (CMFp). The infants will be assessed by a local paediatricians using the Cow's Milk-related Symptom Score (CoMiSS). This is a fast, non-invasive and easy-to-use and validated questionnaire to assess infant's reaction to proteins found in cow's milk. The higher the score, the more sensitive the child is to cow's milk proteins, the maximum score is 33 points. Infants with a CoMiSS Score between 6 and 12 will be enrolled in this study. It is expected that infants will have a better response to GMF, which will result in a decrease of the CoMiSS Score after a 2 weeks intervention.
- Conditions
- Gastrointestinal Diseases, Cow's Milk Intolerance
- Being tested
- Goat milk-based infant formula, Cow's milk-based infant formula with probiotic drops
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goat milk-based infant formulaDietary supplement
Infant formula based on goat milk for 4 weeks at volume depending on the infant
Cow's milk-based infant formula with probiotic dropsDietary supplement
Infant formula based on cow's milk with probiotic Lactobacillus reuteri drops for 4 weeks at volume depending on the infant
| Study group | Role | What they receive |
|---|---|---|
| Goat milk-based formula | Experimental | goat milk-based infant formula (GMF) Receives: Dietary Supplement: Goat milk-based infant formula |
| Cow's milk-based formula | Placebo comparator | cow's milk-based infant formula supplemented with probiotics (CMFp) Receives: Dietary Supplement: Cow's milk-based infant formula with probiotic drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cow's Milk-related Symptoms
Difference in Cow's Milk related Symptom Score (CoMiSS: score ranges from 0 to 33 with higher scores indicating more symptoms) at baseline and after 14 days of intervention.
Measured: 0-2 weeks
Secondary outcomes (8)
Cow's Milk-related Symptoms
Difference in Cow's Milk-related Symptoms Score (CoMiSS: score ranges from 0 to 33 with higher scores indicating more symptoms) at baseline and after 28 days of intervention.
Measured: 0-4 weeks
Parental stress
Difference in parental stress measured by Parental Stress Index-Short Form (PSI-SF: score ranges from 15% to 100% with higher scores indicating more stress) at baseline, after 5 days, after 9 days and after 28 days of intervention.
Measured: 0-4 weeks
Parental quality of life
Difference in parental quality of life measured by World Health Organization Quality Of Life questionnaire - short version (WHOQOL-BREF: score ranges from 0 to 100 with higher scores indicating better quality of life ) at baseline, after 5 days, after 9 days and after 28 days of intervention.
Measured: 0-4 weeks
Weight
Difference in weight (grams) at baseline, after 14 days and after 28 days of intervention.
Measured: 0-4 weeks
Length
Difference in length (cm) at baseline, after 14 days and after 28 days of intervention.
Measured: 0-4 weeks
Weight-for-age
Difference in weight-for-age z-scores calculated using the World Health Organization Child Growth Standards at baseline, after 14 days and after 28 days of intervention.
Measured: 0-4 weeks
Length-for-age
Difference in length-for-age z-scores calculated using the World Health Organization Child Growth Standards at baseline, after 14 days and after 28 days of intervention.
Measured: 0-4 weeks
Weight-for-length
Difference in weight-for-length z-scores calculated using the World Health Organization Child Growth Standards at baseline, after 14 days and after 28 days of intervention.
Measured: 0-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 May 2019
- Primary completion1 Apr 2021
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled pilot study
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ausnutria Hyproca B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HM hospitales
- Responsible party
- Sponsor
- Investigators
- Alejandro López-Escobar, Dr., Principal investigator, Hospital Universitario General de Villalba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301139
- Sponsor's protocol ID
- P17-004
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess Improvement of Digestive Symptoms With Goat's Milk Infant Formula.
- ClinicalTrials.gov ID
- NCT06301139
- Acronym / sponsor ID
- P17-004
- Conditions
- Gastrointestinal Diseases, Cow's Milk Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ausnutria Hyproca B.V.Industry (pharma, biotech, devices)
- Collaborators
- HM hospitales
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 8 Mar 2024 (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.
In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops.
Detailed description
Anecdotal evidence shows that the use of goat milk-based infant formula decreases discomfort of infants with cow's milk related symptoms. In this randomized controlled pilot study, the effect on comfort during usage of goat-milk based infant formula is studied. Twenty formula fed infants (aged between 6 weeks and 3 months) who experience mild discomfort will receive goat milk-based infant formula (GMF) or cow's mik based infant formula supplemented with probiotics lactobacillus reuteri drops (CMFp). The infants will be assessed by a local paediatricians using the Cow's Milk-related Symptom Score (CoMiSS). This is a fast, non-invasive and easy-to-use and validated questionnaire to assess infant's reaction to proteins found in cow's milk. The higher the score, the more sensitive the child is to cow's milk proteins, the maximum score is 33 points. Infants with a CoMiSS Score between 6 and 12 will be enrolled in this study. It is expected that infants will have a better response to GMF, which will result in a decrease of the CoMiSS Score after a 2 weeks intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| Goat milk-based formula | Experimental | Dietary Supplement: Goat milk-based infant formulagoat milk-based infant formula (GMF) |
| Cow's milk-based formula | Placebo comparator | Dietary Supplement: Cow's milk-based infant formula with probiotic dropscow's milk-based infant formula supplemented with probiotics (CMFp) |
Who may qualify
- Ages
- 6 weeks to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy full-term infant with birth weight ≥2,500 to ≤4,500 g
- Infant aged between 4 weeks and 3 months at enrolment
- CoMiSS value at baseline between 6 and 12
- Infant is exclusively bottle fed with cow's milk based infant formula at baseline
Key exclusion criteria (7 listed)
- Breastfed infants
- Congenital illness or malformation that may affect infant feeding or normal growth
- Gastrointestinal disorders
- Confirmed cow or goat milk protein allergy or lactose intolerance
- Supplemental feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goat milk-based infant formulaInfant formula based on goat milk for 4 weeks at volume depending on the infant | Dietary supplement | Goat milk-based formula |
| Cow's milk-based infant formula with probiotic dropsInfant formula based on cow's milk with probiotic Lactobacillus reuteri drops for 4 weeks at volume depending on the infant | Dietary supplement | Cow's milk-based formula |
Primary outcome
Cow's Milk-related Symptoms
Time frame: 0-2 weeks
Difference in Cow's Milk related Symptom Score (CoMiSS: score ranges from 0 to 33 with higher scores indicating more symptoms) at baseline and after 14 days of intervention.
8 secondary outcomes
Cow's Milk-related Symptoms
Time frame: 0-4 weeks
Parental stress
Time frame: 0-4 weeks
Parental quality of life
Time frame: 0-4 weeks
Weight
Time frame: 0-4 weeks
Length
Time frame: 0-4 weeks
Weight-for-age
Time frame: 0-4 weeks
Length-for-age
Time frame: 0-4 weeks
Weight-for-length
Time frame: 0-4 weeks
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 8 Mar 2024.
- 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.
Alejandro López-Escobar, Dr. principal investigator
Hospital Universitario General de Villalba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goat milk-based infant formula and Cow's milk-based infant formula with probiotic drops in people with Gastrointestinal Diseases and Cow's Milk Intolerance, run by Ausnutria Hyproca B.V. at 1 site in Spain.
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 4 inclusion and 7 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 8 Mar 2024. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Cow's Milk-related Symptoms (time frame: 0-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.