Cow's Milk Intolerance, Gastrointestinal Diseases
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGoat milk-based infant formula
Infant formula based on goat milk for 4 weeks at volume depending on the infant
DIETARY_SUPPLEMENTCow's milk-based infant formula with probiotic drops
Infant formula based on cow's milk with probiotic Lactobacillus reuteri drops for 4 weeks at volume depending on the infant
Sponsors
HM hospitales
Ausnutria Hyproca B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized controlled pilot study
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 3 Months
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Weight | 0-4 weeks | Difference in weight (grams) at baseline, after 14 days and after 28 days of intervention. |
| 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-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. |
Countries
Spain
Outcome results
None listed