Goat Milk Infant Formula Comfort Study

Gastrointestinal Diseases Clinical Trial

Official title:

Clinical Trial to Assess Improvement of Digestive Symptoms With Goat's Milk Infant Formula.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06301139
• Other study ID #: P17-004
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Ausnutria Hyproca B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 1, 2024
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Lactose Intolerance

Intervention

Dietary Supplement:
• Goat milk-based infant formula
Infant formula based on goat milk for 4 weeks at volume depending on the infant
• Cow'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

Locations

Country	Name	City	State
Spain	HM hospitales	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Ausnutria Hyproca B.V.	HM hospitales

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cow's Milk-related Symptoms	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.	0-2 weeks
Secondary	Cow's Milk-related Symptoms	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.	0-4 weeks
Secondary	Parental stress	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.	0-4 weeks
Secondary	Parental quality of life	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.	0-4 weeks
Secondary	Weight	Difference in weight (grams) at baseline, after 14 days and after 28 days of intervention.	0-4 weeks
Secondary	Length	Difference in length (cm) at baseline, after 14 days and after 28 days of intervention.	0-4 weeks
Secondary	Weight-for-age	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.	0-4 weeks
Secondary	Length-for-age	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.	0-4 weeks
Secondary	Weight-for-length	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.	0-4 weeks