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

Not Applicable

Not yet recruiting

• Conditions: Infant Nutrition Disorders; Gastrointestinal Diseases

• Registration Number: NCT06108401
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-24
• Last Update Submitted: 2023-10-24
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31
• Study Start: 2023-11-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks	0 - 4 weeks	Proportion of infants with a reduction of 4 points or more in the CoMiSS value

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Paediatrics, The Medical University of Warsaw, Poland; 🇵🇱 Warsaw, Poland