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

NCT06108401 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2023-10-31

No results posted yet for this study

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.

Conditions

  • Infant Nutrition Disorders
  • Gastrointestinal Diseases

Interventions

DIETARY_SUPPLEMENT

Goat milk-based infant formula

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

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.

Sponsors & Collaborators

  • Ausnutria Hyproca B.V.

    collaborator INDUSTRY

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Mateusz Jankiewicz, MD · Department of Paediatrics, The Medical University of Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Days
Max Age
90 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06108401 on ClinicalTrials.gov