NCT01072084

Brief Summary

The purpose of this study is to evaluate the endoscopic diagnostic options of the endomicroscopy in patients with food intolerance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 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

February 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 7, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

February 18, 2010

Last Update Submit

February 18, 2022

Conditions

Food Allergy

Keywords

food allergyconfocal laser endoscopediagnosisDiagnosis of food allergy

Outcome Measures

Primary Outcomes (1)

  • The degree of oedema formation, the amount of cell infiltration and the expansion of lymph nodes.

    Two years

Study Arms (2)

Patients with food allergy

Healthy subjects

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Both study groups will be acquired from the ambulant gastrointestinal consultation of the Medical department 1 of the Universityhospital Erlangen.

You may qualify if:

  • new diagnosed and not treated patients with food allergy

You may not qualify if:

  • decreased clotting (Quick \< 50%, platelet \< 50.000/µl)
  • not given consent
  • known allergy against fluorescein
  • pregnant and breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Department 1, University hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (1)

  • Kiesslich R, Goetz M, Lammersdorf K, Schneider C, Burg J, Stolte M, Vieth M, Nafe B, Galle PR, Neurath MF. Chromoscopy-guided endomicroscopy increases the diagnostic yield of intraepithelial neoplasia in ulcerative colitis. Gastroenterology. 2007 Mar;132(3):874-82. doi: 10.1053/j.gastro.2007.01.048. Epub 2007 Jan 31.

    PMID: 17383417BACKGROUND

MeSH Terms

Conditions

Food HypersensitivityDisease

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Raithel, MD

    Medical Department 1, University hospital Erlangen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 7, 2022

Record last verified: 2022-02

Locations

DE(1)