Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.

Conditions
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Infant Nutrition Disorders, Gastrointestinal Diseases

Intervention / Treatment
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* Dietary Supplement: Goat milk-based infant formula
* Dietary Supplement: Cow milk-based infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 14 Days
Maximum Age: 90 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goat milk formula-fed group<br>79 participants | Dietary Supplement: Goat milk-based infant formula<br>* Goat milk-based infant formula exclusively for 4 weeks at a volume depending on the infant.<br>|
| Placebo Comparator: Cow milk formula-fed group<br>79 participants | Dietary Supplement: Cow milk-based infant formula<br>* Regular cow milk-based infant formula that is similar in color, smell, and taste to the formula received by the experimental group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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goat milk, infant formula, nutrition