Siderophore-profile in Allergic and Non-allergic Subjects

Healthy Clinical Trial

Official title:

Linking Iron-deficiency With Allergy- the Role of Microbial Survival Components

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815981
• Other study ID #: 1972/2017
• Status: Completed
• Start date: December 12, 2018
• Est. completion date: December 12, 2021

Study information

• Verified date: March 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to profile the siderophore-content in the human gut from allergic and non-allergic subjects and to assess their contribution in iron homeostasis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 12, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Allergic Sensitisation
• Allergy
• Healthy
• Hypersensitivity

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron status	Hemoglobin, Ferritin, hepcidin, iron and soluble transferrin receptor concentrations, transferrin saturation in %	baseline
Secondary	Siderophore profile	Mass spectrometric analysis of siderophores	baseline