Siderophore-profile in Allergic and Non-allergic Subjects

Sponsor

Medical University of Vienna (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03815981

Collaborator

(none)

Enrollment

Location

47.6

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Allergy Healthy Allergic Sensitisation

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 Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Dec 12, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Allergic Collection of blood, stool, urin samples
Sensitized Collection of blood, stool, urin samples
Non-Allergic Collection of blood, stool, urin samples

Outcome Measures

Primary Outcome Measures

Iron status [baseline]
Hemoglobin, Ferritin, hepcidin, iron and soluble transferrin receptor concentrations, transferrin saturation in %

Secondary Outcome Measures

Siderophore profile [baseline]
Mass spectrometric analysis of siderophores

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).