Clinical trial NCT06108401: Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.
Official title: Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infant Nutrition Disorders
Gastrointestinal Diseases
Keywords: goat milk
infant formula
nutrition
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Ausnutria Hyproca B.V.
First posted: 2023-10-31
Enrollment: 152
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this trial, the investigators aim to assess impact of goat milk-based infant formula on the severity and frequency of gastrointestinal symptoms, as well as other associated symptoms, and the health-related quality of life in infants exhibiting symptoms possibly related to cow's milk, compared to a cow milk-based formula.

Detailed description: Gastrointestinal symptoms are frequent in the first 6 months of life in otherwise healthy infants fed cow milk-based infant formulas (CMF). In management special infant formulas may be considered, although none is routinely recommended. Goat milk-based infant formulas (GMF) have shown promising effects on digestion and increased gastric emptying in several in vitro studies.

In this trial, a total of 158 participants at age 14 to 90 days, who exhibit gastrointestinal and/or other symptoms associated with CMF consumption, as assessed with the Cow's Milk-related Symptom Score (CoMiSS) between 6 and 10 will be randomly allocated to GMF or CMF for four weeks. The primary outcome will be the proportion of infants showing a reduction of at least 4 points in CoMiSS following the four-week intervention period.

Eligibility criteria: Inclusion Criteria:

* Healthy term infants with a gestational age between 37 and 42 weeks.
* Infants who have received cow's milk infant formula for at least 7 consecutive days.
* Exclusive formula feeding.
* Cow's Milk-related Symptoms Score (CoMiSS) value at baseline between ≥6 and \<10.

Exclusion Criteria:

* exclusive or partial breastfeeding (or feeding human milk)
* introduced to solid food/supplementary feeding
* any congenital or chronic condition
* previous or present gastrointestinal illness or malformation that could interfere with study parameters
* diagnosed cow's milk allergy
* receiving medication with regard to functional gastrointestinal disorders (i.e., reflux medication)
* sibling already participating in this study, and/or participating in another clinical trial.

Primary outcomes:
measure: Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks
timeFrame: 0 - 4 weeks
Secondary outcomes:
measure: Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks
timeFrame: 0 - 2 weeks
measure: Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks
timeFrame: 0 - 2 weeks
measure: Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks
timeFrame: 0 - 4 weeks
measure: The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 2 weeks
timeFrame: 0 - 2 weeks
measure: The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 4 weeks
timeFrame: 0 - 4 weeks
measure: Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 2 weeks
timeFrame: 0 - 2 weeks
measure: Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 4 weeks
timeFrame: 0 - 4 weeks
measure: Anthropometric parameters after 2 weeks
timeFrame: 0 - 2 weeks
measure: Anthropometric parameters after 4 weeks
timeFrame: 0 - 4 weeks
measure: Adverse events
timeFrame: 0 - 4 weeks
measure: Anthropometric parameters after 2 weeks
timeFrame: 0 - 2 weeks
measure: Anthropometric parameters after 4 weeks
timeFrame: 0 - 4 weeks
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Paediatrics, The Medical University of Warsaw, Poland
Study officials:
affiliation: Department of Paediatrics, The Medical University of Warsaw, Poland
name: Mateusz Jankiewicz, MD
role: PRINCIPAL_INVESTIGATOR
References: