NCT06108401

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

October 17, 2023

Last Update Submit

October 24, 2023

Conditions

Infant Nutrition DisordersGastrointestinal Diseases

Keywords

goat milkinfant formulanutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Reduction of Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks

    0 - 2 weeks

  • Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 2 weeks

    0 - 2 weeks

  • Difference in Cow's Milk-related Symptoms Score (CoMiSS) values after 4 weeks

    0 - 4 weeks

  • The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 2 weeks

    0 - 2 weeks

  • The Pediatric Quality of Life Inventory (PedsQL) Infant Scales improvement after 4 weeks

    0 - 4 weeks

  • +7 more secondary outcomes

Study Arms (2)

Goat milk formula-fed group

EXPERIMENTAL

79 participants

Dietary Supplement: Goat milk-based infant formula

Cow milk formula-fed group

PLACEBO COMPARATOR

79 participants

Dietary Supplement: Cow milk-based infant formula

Interventions

Goat milk-based infant formulaDIETARY_SUPPLEMENT

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

Goat milk formula-fed group
Cow milk-based infant formulaDIETARY_SUPPLEMENT

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

Cow milk formula-fed group

Eligibility Criteria

Age14 Days - 90 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Paediatrics, The Medical University of Warsaw, Poland

Warsaw, 01-183, Poland

Location

MeSH Terms

Conditions

Infant Nutrition DisordersGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesDigestive System Diseases

Study Officials

  • Mateusz Jankiewicz, MD

    Department of Paediatrics, The Medical University of Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mateusz Jankiewicz, MD

CONTACT

+ 48 22 317 94 21mateusz.j.jankiewicz@gmail.com

Hanna Szajewska, MD, PhD

CONTACT

+ 48 22 317 94 21hanna.szajewska@wum.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 31, 2023

Study Start

November 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

PL(1)