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

Medical University of Warsaw

Status: Not yet enrolling

Conditions: Gastrointestinal Diseases; Infant Nutrition Disorders

Treatments: Dietary Supplement: Goat milk-based infant formula; Dietary Supplement: Cow milk-based infant formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06108401

GMF-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 estimated patients

Sex: All

Ages: 14 to 90 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 2 patient groups, including a placebo group

Goat milk formula-fed group

Experimental group

Description:

79 participants

Treatment:

Dietary Supplement: Goat milk-based infant formula

Cow milk formula-fed group

Placebo Comparator group

Description:

79 participants

Treatment:

Dietary Supplement: Cow milk-based infant formula