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

October 24, 2023 updated by: Medical University of Warsaw
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland, 01-183
        • Department of Paediatrics, The Medical University of Warsaw, Poland
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Goat milk formula-fed group
79 participants
Dietary supplement: Goat milk-based infant formula
Goat milk-based infant formula exclusively for 4 weeks at a volume depending on the infant.
Placebo Comparator: Cow milk formula-fed group
79 participants
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

Ausnutria Hyproca B.V.

Investigators

  • Principal Investigator: Mateusz Jankiewicz, MD, Department of Paediatrics, The Medical University of Warsaw, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMF-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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