Goat Milk Infant Formula Comfort Study
- Conditions
- Gastrointestinal DiseasesCow's Milk Intolerance
- Interventions
- Dietary Supplement: Cow's milk-based infant formula with probiotic dropsDietary Supplement: Goat milk-based infant formula
- Registration Number
- NCT06301139
- Lead Sponsor
- Ausnutria Hyproca B.V.
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cow's milk-based formula Cow's milk-based infant formula with probiotic drops cow's milk-based infant formula supplemented with probiotics (CMFp) Goat milk-based formula Goat milk-based infant formula goat milk-based infant formula (GMF)
- Primary Outcome Measures
Name Time Method Cow's Milk-related Symptoms 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.
- Secondary Outcome Measures
Name Time Method Cow's Milk-related Symptoms 0-4 weeks 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.
Weight 0-4 weeks Difference in weight (grams) at baseline, after 14 days and after 28 days of intervention.
Weight-for-age 0-4 weeks 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.
Length-for-age 0-4 weeks 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.
Weight-for-length 0-4 weeks 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.
Length 0-4 weeks Difference in length (cm) at baseline, after 14 days and after 28 days of intervention.
Parental stress 0-4 weeks 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.
Parental quality of life 0-4 weeks 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.
Trial Locations
- Locations (1)
HM hospitales
🇪🇸Madrid, Spain