An interventional study of Goat milk-based infant formula and Cow's milk-based infant formula with probiotic drops in Gastrointestinal Diseases and Cow's Milk Intolerance, sponsored by Ausnutria Hyproca B.V.. Completed at 1 site in Spain. Open to participants aged 6 Weeks to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Ausnutria Hyproca B.V. · Not applicable, Interventional, and Treatment
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.
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.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's enrollment of 18 is below the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Ausnutria Hyproca B.V. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
goat milk-based infant formula (GMF)
Dietary Supplement: Goat milk-based infant 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 goat milk for 4 weeks at volume depending on the infant
Infant formula based on cow's milk with probiotic Lactobacillus reuteri drops for 4 weeks at volume depending on the infant
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.
Time frame: 0-2 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 0-4 weeks
Weight
Difference in weight (grams) at baseline, after 14 days and after 28 days of intervention.
Time frame: 0-4 weeks
Length
Difference in length (cm) at baseline, after 14 days and after 28 days of intervention.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0-4 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ausnutria Hyproca B.V.