Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.

Gastrointestinal Diseases Clinical Trial

Official title:

Effect Of a Goat Milk-Based Infant Formula On Gastrointestinal And Other Symptoms And Health-Related Quality Of Life.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06108401
• Other study ID #: GMF-2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Medical University of Warsaw
• Contact: Mateusz Jankiewicz, MD
• Phone: + 48 22 317 94 21
• Email: mateusz.j.jankiewicz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Days to 90 Days

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Infant Nutrition Disorders
• Nutrition Disorders

Intervention

Dietary Supplement:
• Goat milk-based infant formula
Goat milk-based infant formula exclusively for 4 weeks at a volume depending on the infant.
• Cow milk-based infant formula
Regular cow milk-based infant formula that is similar in color, smell, and taste to the formula received by the experimental group.

Locations

Country	Name	City	State
Poland	Department of Paediatrics, The Medical University of Warsaw, Poland	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Ausnutria Hyproca B.V.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks	Proportion of infants with a reduction of 4 points or more in the CoMiSS value	0 - 4 weeks
Secondary	Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks	Proportion of infants with a reduction of 4 points or more in the CoMiSS value	0 - 2 weeks
Secondary	Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks	Difference in the CoMiSS between infants fed with goat milk-based infant formula versus cow milk-based infant formula	0 - 2 weeks
Secondary	Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks	Difference in the CoMiSS between infants fed with goat milk-based infant formula versus cow milk-based infant formula	0 - 4 weeks
Secondary	The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 2 weeks	Proportion of infants with a PedsQL Infant Scale score of 80 or higher	0 - 2 weeks
Secondary	The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 4 weeks	Proportion of infants with a PedsQL Infant Scale score of 80 or higher	0 - 4 weeks
Secondary	Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 2 weeks	Change in the severity and frequency of gastrointestinal symptoms as measured by the IGSQ	0 - 2 weeks
Secondary	Improvement in gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) after 4 weeks	Change in the severity and frequency of gastrointestinal symptoms as measured by the IGSQ	0 - 4 weeks
Secondary	Anthropometric parameters after 2 weeks	Assessment of growth parameters, including weight	0 - 2 weeks
Secondary	Anthropometric parameters after 4 weeks	Assessment of growth parameters, including weight	0 - 4 weeks
Secondary	Adverse events	Adverse events throughout the study period	0 - 4 weeks
Secondary	Anthropometric parameters after 2 weeks	Assessment of growth parameters, including length	0 - 2 weeks
Secondary	Anthropometric parameters after 4 weeks	Assessment of growth parameters, including length	0 - 4 weeks