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NCT05178004
Microbiome and Immune Profiling in Infant With Cow's Milk Allergy
trial testing Faecal and Urine sample collection in Cow Milk Allergy in 150 participants. Status unknown.
1 December 2022
Quick facts
| Lead sponsor | University of Glasgow |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 1 August 2018 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Faecal and Urine sample collection
Conditions studied
- Cow Milk Allergy — all drugs for Cow Milk Allergy →
Sponsor
University of Glasgow
Who can join
Under 16 Weeks, any sex, with Cow Milk Allergy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05178004
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Related trials
Other recruiting trials for Cow Milk Allergy
Currently open trials in the same condition.
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- NCT05785299 — Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy · NA · recruiting
- NCT04249973 — Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children · active not recruiting
Other University of Glasgow trials
Trials by the same sponsor.
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- NCT06895837 — Effect of Exercise on Appetite in Response to Meals During Energy Restriction · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05178004 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Glasgow
- Last refreshed: 1 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05178004.
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