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| Name | Class |
|---|---|
| Ausnutria Hyproca B.V. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goat milk formula-fed group | Experimental | 79 participants |
|
| Cow milk formula-fed group | Placebo Comparator | 79 participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goat milk-based infant formula | Dietary Supplement | Goat milk-based infant formula exclusively for 4 weeks at a volume depending on the infant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0 - 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0 - 2 weeks |
| Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mateusz Jankiewicz, MD | Contact | + 48 22 317 94 21 | mateusz.j.jankiewicz@gmail.com | |
| Hanna Szajewska, MD, PhD | Contact | + 48 22 317 94 21 | hanna.szajewska@wum.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Mateusz Jankiewicz, MD | Department of Paediatrics, The Medical University of Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics, The Medical University of Warsaw, Poland | Warsaw | 01-183 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40676640 | Derived | 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. |
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| Cow milk-based infant formula | Dietary Supplement | Regular cow milk-based infant formula that is similar in color, smell, and taste to the formula received by the experimental group. |
|
Difference in the CoMiSS between infants fed with goat milk-based infant formula versus cow milk-based infant formula
| 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 | 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 | 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 | 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 | 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 | 0 - 4 weeks |
| Anthropometric parameters after 2 weeks | Assessment of growth parameters, including weight | 0 - 2 weeks |
| Anthropometric parameters after 4 weeks | Assessment of growth parameters, including weight | 0 - 4 weeks |
| Adverse events | Adverse events throughout the study period | 0 - 4 weeks |
| Anthropometric parameters after 2 weeks | Assessment of growth parameters, including length | 0 - 2 weeks |
| Anthropometric parameters after 4 weeks | Assessment of growth parameters, including length | 0 - 4 weeks |
| ID | Term |
|---|---|
| D007228 | Infant Nutrition Disorders |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004066 | Digestive System Diseases |
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