Infant Nutrition DisordersNCT06108401
Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.
A study testing Goat milk-based infant formula and Cow milk-based infant formula in people with Infant Nutrition Disorders and Gastrointestinal Diseases, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
In this trial, the investigators aim to assess impact of goat milk-based infant formula on the severity and frequency of gastrointestinal symptoms, as well as other associated symptoms, and the health-related quality of life in infants exhibiting symptoms possibly related to cow's milk, compared to a cow milk-based… Read more about this study
- Who is it for?
- Ages 14 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition Disorders, Gastrointestinal Diseases
- What is being tested?
- Goat milk-based infant formula and Cow milk-based infant formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2023to 31 Dec 2025
- 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 14 to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants with a gestational age between 37 and 42 weeks.
- Infants who have received cow's milk infant formula for at least 7 consecutive days.
- Exclusive formula feeding.
- Cow's Milk-related Symptoms Score (CoMiSS) value at baseline between ≥6 and <10.
Who cannot join
- exclusive or partial breastfeeding (or feeding human milk)
- introduced to solid food/supplementary feeding
- any congenital or chronic condition
- previous or present gastrointestinal illness or malformation that could interfere with study parameters
- diagnosed cow's milk allergy
- receiving medication with regard to functional gastrointestinal disorders (i.e., reflux medication)
- sibling already participating in this study, and/or participating in another clinical trial.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Paediatrics, The Medical University of Warsaw, Poland
Warsaw, 01-183
Mateusz Jankiewicz, MD, +48 22 317 95 36, mateusz.j.jankiewicz@gmail.com
About this study
In this trial, the investigators aim to assess impact of goat milk-based infant formula on the severity and frequency of gastrointestinal symptoms, as well as other associated symptoms, and the health-related quality of life in infants exhibiting symptoms possibly related to cow's milk, compared to a cow milk-based formula.
Read the detailed description
Gastrointestinal symptoms are frequent in the first 6 months of life in otherwise healthy infants fed cow milk-based infant formulas (CMF). In management special infant formulas may be considered, although none is routinely recommended. Goat milk-based infant formulas (GMF) have shown promising effects on digestion and increased gastric emptying in several in vitro studies.
In this trial, a total of 158 participants at age 14 to 90 days, who exhibit gastrointestinal and/or other symptoms associated with CMF consumption, as assessed with the Cow's Milk-related Symptom Score (CoMiSS) between 6 and 10 will be randomly allocated to GMF or CMF for four weeks. The primary outcome will be the proportion of infants showing a reduction of at least 4 points in CoMiSS following the four-week intervention period.
- Being tested
- Goat milk-based infant formula, Cow milk-based infant formula
- Keywords
- goat milk, infant formula, nutrition
- Medical subject headings
- Infant Nutrition Disorders, 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
Goat milk-based infant formula exclusively for 4 weeks at a volume depending on the infant.
Cow milk-based infant formulaDietary supplement
Regular cow milk-based infant formula that is similar in color, smell, and taste to the formula received by the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Goat milk formula-fed group | Experimental | 79 participants Receives: Dietary Supplement: Goat milk-based infant formula |
| Cow milk formula-fed group | Placebo comparator | 79 participants Receives: Dietary Supplement: Cow milk-based infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks
Proportion of infants with a reduction of 4 points or more in the CoMiSS value
Measured: 0 - 4 weeks
Secondary outcomes (12)
Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks
Proportion of infants with a reduction of 4 points or more in the CoMiSS value
Measured: 0 - 2 weeks
Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks
Difference in the CoMiSS between infants fed with goat milk-based infant formula versus cow milk-based infant formula
Measured: 0 - 2 weeks
Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks
Difference in the CoMiSS between infants fed with goat milk-based infant formula versus cow milk-based infant formula
Measured: 0 - 4 weeks
The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 2 weeks
Proportion of infants with a PedsQL Infant Scale score of 80 or higher
Measured: 0 - 2 weeks
The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 4 weeks
Proportion of infants with a PedsQL Infant Scale score of 80 or higher
Measured: 0 - 4 weeks
Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 2 weeks
Change in the severity and frequency of gastrointestinal symptoms as measured by the IGSQ
Measured: 0 - 2 weeks
Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 4 weeks
Change in the severity and frequency of gastrointestinal symptoms as measured by the IGSQ
Measured: 0 - 4 weeks
Anthropometric parameters after 2 weeks
Assessment of growth parameters, including weight
Measured: 0 - 2 weeks
Anthropometric parameters after 4 weeks
Assessment of growth parameters, including weight
Measured: 0 - 4 weeks
Adverse events
Adverse events throughout the study period
Measured: 0 - 4 weeks
Anthropometric parameters after 2 weeks
Assessment of growth parameters, including length
Measured: 0 - 2 weeks
Anthropometric parameters after 4 weeks
Assessment of growth parameters, including length
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 posted31 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Infant Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Ausnutria Hyproca B.V.
- Responsible party
- Sponsor
- Investigators
- Mateusz Jankiewicz, MD, Principal investigator, Department of Paediatrics, The Medical University of Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108401
- Sponsor's protocol ID
- GMF-2023
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jankiewicz M, Szajewska H. Protocol for a randomized trial comparing a synbiotic-enriched goat milk-based infant formula with a commercially available cow milk-based formula: effects on gastrointestinal symptoms, quality of life, and growth in infants with cow milk-related symptoms. Nutr J. 2025 Jul 17;24(1):114. doi: 10.1186/s12937-025-01183-9.
PubMed 40676640
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.
- ClinicalTrials.gov ID
- NCT06108401
- Acronym / sponsor ID
- GMF-2023
- Keywords
- goat milk, infant formula, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Ausnutria Hyproca B.V.
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Oct 2023 (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 trial, the investigators aim to assess impact of goat milk-based infant formula on the severity and frequency of gastrointestinal symptoms, as well as other associated symptoms, and the health-related quality of life in infants exhibiting symptoms possibly related to cow's milk, compared to a cow milk-based formula.
Detailed description
Gastrointestinal symptoms are frequent in the first 6 months of life in otherwise healthy infants fed cow milk-based infant formulas (CMF). In management special infant formulas may be considered, although none is routinely recommended. Goat milk-based infant formulas (GMF) have shown promising effects on digestion and increased gastric emptying in several in vitro studies.
In this trial, a total of 158 participants at age 14 to 90 days, who exhibit gastrointestinal and/or other symptoms associated with CMF consumption, as assessed with the Cow's Milk-related Symptom Score (CoMiSS) between 6 and 10 will be randomly allocated to GMF or CMF for four weeks. The primary outcome will be the proportion of infants showing a reduction of at least 4 points in CoMiSS following the four-week intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goat milk formula-fed group | Experimental | Dietary Supplement: Goat milk-based infant formula79 participants |
| Cow milk formula-fed group | Placebo comparator | Dietary Supplement: Cow milk-based infant formula79 participants |
Who may qualify
- Ages
- 14 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy term infants with a gestational age between 37 and 42 weeks.
- Infants who have received cow's milk infant formula for at least 7 consecutive days.
- Exclusive formula feeding.
- Cow's Milk-related Symptoms Score (CoMiSS) value at baseline between ≥6 and <10.
Key exclusion criteria (7 listed)
- exclusive or partial breastfeeding (or feeding human milk)
- introduced to solid food/supplementary feeding
- any congenital or chronic condition
- previous or present gastrointestinal illness or malformation that could interfere with study parameters
- diagnosed cow's milk allergy
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 formulaGoat milk-based infant formula exclusively for 4 weeks at a volume depending on the infant. | Dietary supplement | Goat milk formula-fed group |
| Cow milk-based infant formulaRegular cow milk-based infant formula that is similar in color, smell, and taste to the formula received by the experimental group. | Dietary supplement | Cow milk formula-fed group |
Primary outcome
Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks
Time frame: 0 - 4 weeks
Proportion of infants with a reduction of 4 points or more in the CoMiSS value
12 secondary outcomes
Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks
Time frame: 0 - 2 weeks
Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks
Time frame: 0 - 2 weeks
Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks
Time frame: 0 - 4 weeks
The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 2 weeks
Time frame: 0 - 2 weeks
The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 4 weeks
Time frame: 0 - 4 weeks
Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 2 weeks
Time frame: 0 - 2 weeks
Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 4 weeks
Time frame: 0 - 4 weeks
Anthropometric parameters after 2 weeks
Time frame: 0 - 2 weeks
Anthropometric parameters after 4 weeks
Time frame: 0 - 4 weeks
Adverse events
Time frame: 0 - 4 weeks
Anthropometric parameters after 2 weeks
Time frame: 0 - 2 weeks
Anthropometric parameters after 4 weeks
Time frame: 0 - 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 40676640Jankiewicz M, Szajewska H. Protocol for a randomized trial comparing a synbiotic-enriched goat milk-based infant formula with a commercially available cow milk-based formula: effects on gastrointestinal symptoms, quality of life, and growth in infants with cow milk-related symptoms. Nutr J. 2025 Jul 17;24(1):114. doi: 10.1186/s12937-025-01183-9.
Related trials for Infant Nutrition Disorders
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruitingObservational study
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Cardiac Abnormalities, Nutrient Intake
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
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.
Mateusz Jankiewicz, MD principal investigator
Department of Paediatrics, The Medical University of Warsaw, Poland
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 milk-based infant formula in people with Infant Nutrition Disorders and Gastrointestinal Diseases, run by Medical University of Warsaw at 1 site in Poland.
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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mateusz Jankiewicz, MD (+ 48 22 317 94 21, mateusz.j.jankiewicz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks (time frame: 0 - 4 weeks). 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 NCT06108401, 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 31 Oct 2023.