- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03815981
Siderophore-profile in Allergic and Non-allergic Subjects
Linking Iron-deficiency With Allergy- the Role of Microbial Survival Components
Study Overview
Status
Conditions
Detailed Description
Iron is an essential nutrient for the majority of commensal bacteria, which commonly secrete siderophores to liberate iron from their surroundings. In several studies, a misbalanced microbiota has been demonstrated in allergics suggesting that also their siderophore profile is severely attenuated.
There are currently no data and very limited knowledge present on the composition of bacterial surviving factors in humans, or on their impact on the human immune system.
As such, 1) the iron status, 2) the microbial biota composition and the 3) siderophore-profile in allergics and non-allergics will be assessed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Vienna, Austria, 1090
- Medical University of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- allergic and non-allergic volunteers
Exclusion Criteria:
- Patients will not be considered for the study if they have co-morbidities such as diabetes mellitus, disorders of the liver including hemochromatosis or kidney, autoimmune or metabolic diseases and malignancy or if they use of medications (e.g. antibiotics, PPIs) that influence the iron, inflammatory or microbial status. Further exclusion criteria are pregnancy, lactation; veganism, zinc, and iron supplementation and smoking. Volunteers will be asked to cease blood donation for at least three months' before recruitment and to cease other supplements for at least two weeks, e.g. vitamins, fish oil or minerals (other than zinc and iron).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Allergic
Collection of blood, stool, urin samples
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Sensitized
Collection of blood, stool, urin samples
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Non-Allergic
Collection of blood, stool, urin samples
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Iron status
Time Frame: baseline
|
Hemoglobin, Ferritin, hepcidin, iron and soluble transferrin receptor concentrations, transferrin saturation in %
|
baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Siderophore profile
Time Frame: baseline
|
Mass spectrometric analysis of siderophores
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Franziska Roth-Walter, PhD, Medical University of Vienna
Publications and helpful links
General Publications
- Petje LM, Jensen SA, Szikora S, Sulzbacher M, Bartosik T, Pjevac P, Hausmann B, Hufnagl K, Untersmayr E, Fischer L, Vyskocil E, Eckl-Dorna J, Jensen-Jarolim E, Hofstetter G, Afify SM, Krenn CG, Roth GA, Rivelles E, Hann S, Roth-Walter F. Functional iron-deficiency in women with allergic rhinitis is associated with symptoms after nasal provocation and lack of iron-sequestering microbes. Allergy. 2021 Sep;76(9):2882-2886. doi: 10.1111/all.14960. Epub 2021 Jun 17. No abstract available.
- Roth-Walter F, Pacios LF, Bianchini R, Jensen-Jarolim E. Linking iron-deficiency with allergy: role of molecular allergens and the microbiome. Metallomics. 2017 Dec 1;9(12):1676-1692. doi: 10.1039/c7mt00241f. Epub 2017 Nov 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1972/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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