Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.
Study Details
Study Description
Brief 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 formula.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Goat milk formula-fed group 79 participants |
Dietary Supplement: Goat milk-based infant formula
Goat milk-based infant formula exclusively for 4 weeks at a volume depending on the infant.
|
| Placebo Comparator: Cow milk formula-fed group 79 participants |
Dietary Supplement: Cow milk-based infant formula
Regular cow milk-based infant formula that is similar in color, smell, and taste to the formula received by the experimental group.
|
Outcome Measures
Primary Outcome Measures
- Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks [0 - 4 weeks]
Proportion of infants with a reduction of 4 points or more in the CoMiSS value
Secondary Outcome Measures
- Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks [0 - 2 weeks]
Proportion of infants with a reduction of 4 points or more in the CoMiSS value
- Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks [0 - 2 weeks]
Difference in the CoMiSS between infants fed with goat milk-based infant formula versus cow milk-based infant formula
- Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks [0 - 4 weeks]
Difference in the CoMiSS between infants fed with goat milk-based infant formula versus cow milk-based infant formula
- The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 2 weeks [0 - 2 weeks]
Proportion of infants with a PedsQL Infant Scale score of 80 or higher
- The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 4 weeks [0 - 4 weeks]
Proportion of infants with a PedsQL Infant Scale score of 80 or higher
- Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 2 weeks [0 - 2 weeks]
Change in the severity and frequency of gastrointestinal symptoms as measured by the IGSQ
- Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 4 weeks [0 - 4 weeks]
Change in the severity and frequency of gastrointestinal symptoms as measured by the IGSQ
- Anthropometric parameters after 2 weeks [0 - 2 weeks]
Assessment of growth parameters, including weight
- Anthropometric parameters after 4 weeks [0 - 4 weeks]
Assessment of growth parameters, including weight
- Adverse events [0 - 4 weeks]
Adverse events throughout the study period
- Anthropometric parameters after 2 weeks [0 - 2 weeks]
Assessment of growth parameters, including length
- Anthropometric parameters after 4 weeks [0 - 4 weeks]
Assessment of growth parameters, including length
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy term infants with a gestational age between 37 and 42 weeks.
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Infants who have received cow's milk infant formula for at least 7 consecutive days.
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Exclusive formula feeding.
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Cow's Milk-related Symptoms Score (CoMiSS) value at baseline between ≥6 and <10.
Exclusion Criteria:
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exclusive or partial breastfeeding (or feeding human milk)
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introduced to solid food/supplementary feeding
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any congenital or chronic condition
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previous or present gastrointestinal illness or malformation that could interfere with study parameters
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diagnosed cow's milk allergy
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receiving medication with regard to functional gastrointestinal disorders (i.e., reflux medication)
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sibling already participating in this study, and/or participating in another clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Paediatrics, The Medical University of Warsaw, Poland | Warsaw | Poland | 01-183 |
Sponsors and Collaborators
- Medical University of Warsaw
- Ausnutria Hyproca B.V.
Investigators
- Principal Investigator: Mateusz Jankiewicz, MD, Department of Paediatrics, The Medical University of Warsaw, Poland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GMF-2023