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

NCT ID: NCT06108401

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-12-31

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.

Conditions

Infant Nutrition Disorders; Gastrointestinal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Goat milk formula-fed group

79 participants

Group Type: EXPERIMENTAL

Goat milk-based infant formula

Intervention Type: DIETARY_SUPPLEMENT

Goat milk-based infant formula exclusively for 4 weeks at a volume depending on the infant.

Cow milk formula-fed group

79 participants

Group Type: PLACEBO_COMPARATOR

Cow milk-based infant formula

Intervention Type: DIETARY_SUPPLEMENT

Regular cow milk-based infant formula that is similar in color, smell, and taste to the formula received by the experimental group.

Interventions

Goat milk-based infant formula

Goat milk-based infant formula exclusively for 4 weeks at a volume depending on the infant.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 14 Days
• Maximum Eligible Age: 90 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ausnutria Hyproca B.V.

INDUSTRY

Sponsor Role: collaborator

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mateusz Jankiewicz, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatrics, The Medical University of Warsaw, Poland

Locations

Department of Paediatrics, The Medical University of Warsaw, Poland

Warsaw, , Poland

Countries

Poland

Central Contacts

Mateusz Jankiewicz, MD

Role: CONTACT

mateusz.j.jankiewicz@gmail.com

+ 48 22 317 94 21

Hanna Szajewska, MD, PhD

Role: CONTACT

hanna.szajewska@wum.edu.pl

+ 48 22 317 94 21

Facility Contacts

Mateusz Jankiewicz, MD

Role: primary

mateusz.j.jankiewicz@gmail.com

+48 22 317 95 36

Other Identifiers

GMF-2023

Identifier Type: -

Identifier Source: org_study_id