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

• Sponsor: University of Erlangen-Nürnberg Medical School (Other)
• Overall Status: Completed
• CT.gov ID: NCT02293343
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Duration (Months): 31
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Allergy; IBS	Other: blood profile

Study Design

• Study Type: Observational
• Actual Enrollment: 65 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: 24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance: Correlations Between Subjective Affliction and Measured Histamine Parameter
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Histamine [24 hrs]

Secondary Outcome Measures

1. diaminoxidase [24 hrs]

Other Outcome Measures

1. TNF alpha [24 hrs]

2. IgE [24 hrs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy subjects

• appropriate invalid persons

Exclusion Criteria:

• pregnant and weaning persons

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Erlangen	Erlangen		Germany	91054

Sponsors and Collaborators

• University of Erlangen-Nürnberg Medical School

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Erlangen-Nürnberg Medical School
• ClinicalTrials.gov Identifier: NCT02293343
• Other Study ID Numbers: Histamine profile 1
• First Posted: Nov 18, 2014
• Last Update Posted: May 11, 2017
• Last Verified: May 1, 2017

• Keywords provided by University of Erlangen-Nürnberg Medical School: histamine profile; IgE Antibodies
• Additional relevant MeSH terms: Food Intolerance

Study Results

No Results Posted as of May 11, 2017