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Microbiome and Immune Profiling in Infant With Cow's Milk Allergy

NCT05178004 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-06-01

No results posted yet for this study

Summary

Non-IgE-mediated cow's milk allergy (CMPA) is associated to gastrointestinal symptoms, and its cause remains poorly understood, limiting the identification of specific markers to help with the diagnosis.

Using a non-invasive method, the aim of this study is to identify new protein markers as well as to profile the bacteria (germs) released in stools of infants during the inflammatory process of this condition (acute and recovery phase).

The study group will include infants who are born at term by an uncomplicated birth and diagnosed with non-IgE-mediated CMPA in the first 4 months of life, while the control groups will consist of infants either healthy or infants diagnosed with IgE-mediated CMPA or with a non-allergic gastrointestinal inflammatory condition (NAGIC). All groups will be matched for age, gender, type of feeding and mode of delivery.

Stool, urine and blood samples (the latter only if already taken during the hospital admission in severe cases) will be collected at the acute and the recovery phase of this condition while the patient follows a diary free diet (breast milk or hypoallergenic formula milk).

Protein markers, bacteria and their products will be measured in stool, urine and blood samples. These measurements will be carried out at the University of Glasgow, Human Nutrition Section labs at Glasgow Royal Infirmary and other University of Glasgow research labs as required.

The ultimate aim is to explore the potential role of immune protein markers and bacteria in stools and urine and their possible use in diagnosing the condition non-invasively. Further understanding of the disease's cause may contribute to the development of new infant feed that could provide gut protection.

Conditions

  • Cow Milk Allergy

Interventions

OTHER

Faecal and Urine sample collection

This is an observational study.

Sponsors & Collaborators

  • NHS Greater Glasgow and Clyde Board HQ

    collaborator OTHER

  • Nutricia, Inc.

    collaborator INDUSTRY

  • University of Glasgow

    lead OTHER

Principal Investigators

  • George Raptis · NHS Greater Glasgow and Clyde

Eligibility

Max Age
16 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • United Kingdom

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 NCT05178004 on ClinicalTrials.gov