Goat Milk Infant Formula Comfort Study

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases; Cow's Milk Intolerance
• Intervention / Treatment: Dietary supplement: Goat milk-based infant formula; Dietary supplement: Cow's milk-based infant formula 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28015
    • HM hospitales

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Goat milk-based formula; goat milk-based infant formula (GMF)	Dietary supplement: Goat milk-based infant formula; Infant formula based on goat milk for 4 weeks at volume depending on the infant
Placebo Comparator: Cow's milk-based formula; cow's milk-based infant formula supplemented with probiotics (CMFp)	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Weight	Difference in weight (grams) at baseline, after 14 days and after 28 days of intervention.	0-4 weeks
Length	Difference in length (cm) at baseline, after 14 days and after 28 days of intervention.	0-4 weeks
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
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
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

Collaborators and Investigators

• Sponsor: Ausnutria Hyproca B.V.
• Collaborators: HM hospitales
• Investigators: Principal Investigator: Alejandro López-Escobar, Dr., Hospital Universitario General de Villalba

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Intestinal Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Malabsorption Syndromes; Gastrointestinal Diseases; Digestive System Diseases; Lactose Intolerance
• Other Study ID Numbers: P17-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No