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Completed

NCT Number: NCT06301139

Goat Milk Infant Formula Comfort Study

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.

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Key information

Age range

6 week–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HM hospitales

Madrid, 28015, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goat milk-based infant formula

Dietary Supplement

Infant formula based on goat milk for 4 weeks at volume depending on the infant

Cow's milk-based infant formula with probiotic drops

Dietary Supplement

Infant formula based on cow's milk with probiotic Lactobacillus reuteri drops for 4 weeks at volume depending on the infant

Primary outcomes

  1. Cow's Milk-related Symptoms

    Time frame: 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 outcomes

  1. Cow's Milk-related Symptoms

    Time frame: 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.

  2. Parental stress

    Time frame: 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.

  3. Parental quality of life

    Time frame: 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.

  4. Weight

    Time frame: 0-4 weeks

    Difference in weight (grams) at baseline, after 14 days and after 28 days of intervention.

  5. Length

    Time frame: 0-4 weeks

    Difference in length (cm) at baseline, after 14 days and after 28 days of intervention.

  6. Weight-for-age

    Time frame: 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.

  7. Length-for-age

    Time frame: 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.

  8. Weight-for-length

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ausnutria Hyproca B.V.

Industry

Collaborators

  • HM hospitales

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2024
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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