NCT03815981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2021

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

January 21, 2019

Last Update Submit

March 14, 2023

Conditions

AllergyHealthyAllergic Sensitisation

Keywords

ironsiderophoresallergyallergic sensitisationtrace elements

Outcome Measures

Primary Outcomes (1)

  • Iron status

    Hemoglobin, Ferritin, hepcidin, iron and soluble transferrin receptor concentrations, transferrin saturation in %

    baseline

Secondary Outcomes (1)

  • Siderophore profile

    baseline

Study Arms (3)

Allergic

Collection of blood, stool, urin samples

Sensitized

Collection of blood, stool, urin samples

Non-Allergic

Collection of blood, stool, urin samples

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Allergics and Non-Allergic subjects over 18 years.

You may qualify if:

  • allergic and non-allergic volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

  • 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.

    PMID: 29120476BACKGROUND

  • 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.

    PMID: 34037999DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Stool, Urin samples

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Franziska Roth-Walter, PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 25, 2019

Study Start

December 12, 2018

Primary Completion

November 11, 2021

Study Completion

December 12, 2021

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

AU(1)