24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance

May 10, 2017 updated by: University of Erlangen-Nürnberg Medical School

24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance: Correlations Between Subjective Affliction and Measured Histamine Parameter

Over 24 hrs serum and plasma samples were collected every 3 hrs. With this a day histamine profile was created. 15 healthy persons with 20 patients with a high level of IgE in serum and 20 patients with afflictions but no high IgE level were compared. Measurment of histamine in plasma, urine and stool were realized. In addition to that Diaminoxidase, TNF alpha and IgE Antibodies were measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Universitatsklinikum Erlangen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

healthy subjects, patients with high IgE level and patients with afflictions, but no high IgE level

Description

Inclusion Criteria:

  • healthy subjects
  • appropriate invalid persons

Exclusion Criteria:

  • pregnant and weaning persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
healthy subjects
Other: blood profile
IgE positive
patients with high IgE level in serum
Other: blood profile
IBS patients
patients with afflictions, but no high IgE level and suspicion on histamine intolerance
Other: blood profile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histamine
Time Frame: 24 hrs
24 hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
diaminoxidase
Time Frame: 24 hrs
24 hrs

Other Outcome Measures

Outcome Measure
Time Frame
TNF alpha
Time Frame: 24 hrs
24 hrs
IgE
Time Frame: 24 hrs
24 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Histamine profile 1

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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