Histamine IntoleranceNCT02418221
A Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase Supplementation
A study testing Drawing blood, measuring BP & pulse in people with Histamine Intolerance, run by IPSC AG at 1 site in Austria.
Trial summary
This study aims to define a provocation test for histamine intolerance (aka. biogenic amine intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate this condition. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Histamine Intolerance
- What is being tested?
- Drawing blood, measuring BP & pulse
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons suspected of suffering from BAIS (BAIS Score ≥ 50) according the the questionaire used for histamine intolerance so far
Who cannot join
- pregnancy
- coronary heart disease
- labile hypertension
- bronchial asthma
- periodical therapy using H1-blockers
- chirurgical intervention with the GI tract within the previous 3 months
- participation in a clinical trial within the previous 4 weeks
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Environmental Dermatology and Venereology, Medical University of Graz
Graz, 8036
About this study
Official title: A Doubleblind, Placebo-controlled, Cross-over Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase (DAOSiN®) Supplementation in Case of DAO Enzyme Deficiency
This study aims to define a provocation test for histamine intolerance (aka. biogenic amine intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate this condition.
Read the detailed description
The clinical picture of the so-called histamine intolerance has been described by various authors since the 1990ies. However, the existence of this multifactorial condition is also being contested due to the lack of both a positive definition and unambiguous diagnostics. Various provocation studies using pure histamine or histamine-containing foods support the existence of the disease pattern, however many questions still remain open.
A lack of diamine oxidase (DAO) is considered the etiological cause of the condition. DAO is an enzyme known to degrade a wide array of biogenic amines. The aim of this study is to provoke a response in patients by oral administration of a defined mixture of biogenic amines. By administration of DAO before provocation an attenuation of the symptoms is to be expected.
- Conditions
- Histamine Intolerance
- Being tested
- DAOSiN®/ Placebo & ProvokAmin® Ingestion, Drawing blood, measuring BP & pulse
- Keywords
- histamine, biogenic amines, diamine oxidase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAOSiN®/ Placebo & ProvokAmin® IngestionDietary supplement
Proband is randomly assigned Daosin® or the Placebo before provocation with ProvokAmin®
Drawing blood, measuring BP & pulseProcedure or surgery
Taking of a blood sample and recording of blood pressure \& pulse
| Study group | Role | What they receive |
|---|---|---|
| DAOSiN®/ Placebo & ProvokAmin® Ingestion | Experimental | A sample of blood is drawn from Patient, blood pressure \& pulse are recorded. Patient will ingest 2 capsules of either DAOSiN® or Placebo, followed by 2 tablets of ProvokAmin 20 minutes later. After an additional 40 minutes blood pressure and pulse are recorded and another sample of blood is drawn. Patient is handed a questionaire for self-evaluation to record any symptoms for the following After between 7 and 15 days the whole cycle is repeated switching between active treatment and Placebo. Receives: Dietary Supplement: DAOSiN®/ Placebo & ProvokAmin® Ingestion; Procedure: Drawing blood, measuring BP & pulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of biogenic amine symptoms (determined via symptom score)
The primary parameter is the reduction of clinical symptoms caused by the ingestion of biogenic amines by the preventive oral administration of DAOSiN®. A symptom score quantifying the subjective single symptoms is used as measuring parameter.
Measured: 24 hrs after start of provocation
Secondary outcomes (1)
Serological parameters
These parameters are ascertained: DAO activity and concentration of histamine in serum; blood pressure \& pulse measurement before and 30/60/90 min post provocation
Measured: Up to 90 min after provocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histamine IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- IPSC AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Graz, Sciotec Diagnostic Technologies GmbH
- Responsible party
- Sponsor
- Investigators
- Albert Missbichler, PhD, Study chair, Sciotec Diagnostic Technologies GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418221
- Sponsor's protocol ID
- Provokamin01
- Status last verified
- Apr 2015
- First submitted
- 1 Sep 2014
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Doubleblind, Placebo-controlled, Cross-over Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase (DAOSiN®) Supplementation in Case of DAO Enzyme Deficiency
- ClinicalTrials.gov ID
- NCT02418221
- Acronym / sponsor ID
- Provokamin01
- Conditions
- Histamine Intolerance
- Keywords
- histamine, biogenic amines, diamine oxidase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- IPSC AGIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of Graz, Sciotec Diagnostic Technologies GmbH
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to define a provocation test for histamine intolerance (aka. biogenic amine intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate this condition.
Detailed description
The clinical picture of the so-called histamine intolerance has been described by various authors since the 1990ies. However, the existence of this multifactorial condition is also being contested due to the lack of both a positive definition and unambiguous diagnostics. Various provocation studies using pure histamine or histamine-containing foods support the existence of the disease pattern, however many questions still remain open.
A lack of diamine oxidase (DAO) is considered the etiological cause of the condition. DAO is an enzyme known to degrade a wide array of biogenic amines. The aim of this study is to provoke a response in patients by oral administration of a defined mixture of biogenic amines. By administration of DAO before provocation an attenuation of the symptoms is to be expected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAOSiN®/ Placebo & ProvokAmin® Ingestion | Experimental | Dietary Supplement: DAOSiN®/ Placebo & ProvokAmin® Ingestion, Procedure: Drawing blood, measuring BP & pulseA sample of blood is drawn from Patient, blood pressure \& pulse are recorded. Patient will ingest 2 capsules of either DAOSiN® or Placebo, followed by 2 tablets of ProvokAmin 20 minutes later. After an additional 40 minutes blood pressure and pulse are recorded and another sample of blood is drawn. Patient is handed a questionaire for self-evaluation to record any symptoms for the following After between 7 and 15 days the whole cycle is repeated switching between active treatment and Placebo. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons suspected of suffering from BAIS (BAIS Score ≥ 50) according the the questionaire used for histamine intolerance so far
Key exclusion criteria (7 listed)
- pregnancy
- coronary heart disease
- labile hypertension
- bronchial asthma
- periodical therapy using H1-blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAOSiN®/ Placebo & ProvokAmin® IngestionProband is randomly assigned Daosin® or the Placebo before provocation with ProvokAmin® | Dietary supplement | DAOSiN®/ Placebo & ProvokAmin® Ingestion |
| Drawing blood, measuring BP & pulseTaking of a blood sample and recording of blood pressure \& pulse | Procedure or surgery | DAOSiN®/ Placebo & ProvokAmin® Ingestion |
Primary outcome
Reduction of biogenic amine symptoms (determined via symptom score)
Time frame: 24 hrs after start of provocation
The primary parameter is the reduction of clinical symptoms caused by the ingestion of biogenic amines by the preventive oral administration of DAOSiN®. A symptom score quantifying the subjective single symptoms is used as measuring parameter.
1 secondary outcome
Serological parameters
Time frame: Up to 90 min after provocation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
Related trials for Histamine Intolerance
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Radicle GI Health™ RFY: A Study Assessing the Impact of DAO Supplementation on Gastrointestinal and Other Histamine Intolerance Symptoms
GI Health
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Histamine as a Molecular Transducer of Adaptation to Exercise
Postexercise Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Missbichler, PhD study chair
Sciotec Diagnostic Technologies GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drawing blood, measuring BP & pulse in people with Histamine Intolerance, run by IPSC AG at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of biogenic amine symptoms (determined via symptom score) (time frame: 24 hrs after start of provocation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.