Histamine IntoleranceHCB/2023/0345NCT07006558
Kinetic Study Of Supplementation With The Enzyme Diamine Oxidase In Patients With Histamine Intolerance
A study testing Diamino Oxidase in people with Histamine Intolerance, run by AB Biotek at 1 site in Spain.
Trial summary
The present study was conducted to assess the safety and tolerability of five ascending doses of plant-based DAO enzyme supplement in subjects with symptoms of histamine intolerance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Histamine Intolerance
- What is being tested?
- Diamino Oxidase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jun 2023to 5 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent history of 2 or more symptoms associated to histamine intolerance.
- Altered activity of plasmatic DAO enzyme and/or at least one genetic variants linked to DAO deficiency (rs10156191, rs1049742, rs1049793, rs2052129).
- Not having started a dietary intervention (low histamine diet or DAO supplementation) before the start of this study.
Who cannot join
- Treatment with low-histamine diet and/or dietary DAO enzyme supplementation prior to the study.
- Pharmacological treatment with antibiotics or probiotic supplements within the last month prior to enrollment.
- Breast-feeding or pregnant women.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The present study was conducted to assess the safety and tolerability of five ascending doses of plant-based DAO enzyme supplement in subjects with symptoms of histamine intolerance.
- Conditions
- Histamine Intolerance
- Being tested
- Diamino Oxidase
- Keywords
- diamine oxidase, histamine intolerance, safety, tolerability, pea sprout, diamine oxidase supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diamino OxidaseDietary supplement
The investigational product is a dehydrated power of DAO enzyme from green pea (Pisum sativum L.) sprouts (adiDAO®Veg, DR Healthcare, S.L.U., Barcelona, Spain), with an enzymatic activity > 298 mU/g (> 14,500 kHDU/g).
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 (4.2 mg adiDAO®Veg) | Experimental | Patients receive the standard dose of 4.2 mg of adiDAO®Veg three times a day for a period of 2 weeks. Receives: Dietary Supplement: Diamino Oxidase |
| Phase 2 (8.4 mg adiDAO®Veg) | Experimental | If, after phase 1, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 8.4 mg of adiDAO®Veg three times a day. Receives: Dietary Supplement: Diamino Oxidase |
| Phase 3 (16.8 mg adiDAO®Veg) | Experimental | If, after phase 2, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 16.8 mg of adiDAO®Veg three times a day. Receives: Dietary Supplement: Diamino Oxidase |
| Phase 4 (33.6 mg adiDAO®Veg) | Experimental | If, after phase 3, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 33.6 mg of adiDAO®Veg three times a day. Receives: Dietary Supplement: Diamino Oxidase |
| Phase 5 (67.2 mg adiDAO®Veg) | Experimental | If, after phase 4, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 67.2 mg of adiDAO®Veg three times a day. Receives: Dietary Supplement: Diamino Oxidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events (AEs)
Number of participants with treatment-related adverse events (AEs) experienced during the supplementation, assessed through a questionnaire.
Measured: At "day 14", "day 28", "day 42", "day 56" and "day 70".
Type of adverse effects (AEs)
Symptoms of adverse effects (AEs) experienced during the supplementation, assessed through a questionnaire including the different body systems: gastrointestinal, CNS, respiratory, dermatological).
Measured: At "day 14", "day 28", "day 42", "day 56" and "day 70".
DAO enzymatic activity in serum using a radioextraction immunoassay
DAO enzymatic activity in serum (mU/mL) using a radioextraction immunoassay (REA-3H, Laboratorio Echevarne, Barcelona, Spain).
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Secondary outcomes (38)
Dietary habits
Dietary habits assessed through a dietary weekly record
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Histamine in 24h urine
Histamine in 24h urine
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Hemogram
Hemogram
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Glycemia
Glycemia for safety assessment
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
HbA1c
HbA1c for safety assessment
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Ionogram
Ionogram for safety assessment
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Lipid profile
Lipid profile
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
C-reactive protein
C-reactive protein for safety assessment
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Interleukin-6
Interleukin-6 for safety assessment
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Proteinuria
Proteinuria from urine sample
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Urine sediment
Urine sediment from urine sample for safety assessment
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Gastrointestinal symptoms through Rome IV criteria
Self-reported Gastrointestinal symptoms: Rome IV criteria
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Gastrointestinal symptoms through Bristol Stool Scale
Self-reported Gastrointestinal symptoms: Bristol Stool Scale. Score goes from Type 1 to Type 7. Higher and lower scores mean worse outcome. Middle scores (Type 3-4) are considered normal/healthy stool consistency.
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Gastrointestinal symptoms through Gastrointestinal Quality of Life Index (GIQLI)
Self-reported Gastrointestinal symptoms: Gastrointestinal Quality of Life Index (GIQLI). Score goes from 0 to 144. Higher scores indicate a better outcome.
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Headaches symptoms through MIDAS questionnaire
Self-reported Headaches symptoms through Migraine Disability Assessment Questionnaire (MIDAS) questionnaire. Score goes from 0 to >21 points. Higher scores indicate a worse outcome.
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Headaches symptoms through HIT-6 questionnaire
Self-reported Headaches symptoms through Headache Impact Test-6 (HIT-6) questionnaire. Score goes from 36 to 78. Higher scores indicate a worse outcome.
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Respiratory symptoms through SNOT-22 questionnaire
Self-reported respiratory symptoms through Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire. Score goes from 0 to 110. Higher scores indicate a worse outcome.
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Respiratory symptoms through Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Score goes from 0 to 6. Higher scores indicate a worse outcome.
Self-reported respiratory symptoms through Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Dermatological symptoms through SCORAD index
Self-reported dermatological symptoms through SCORing Atopic Dermatitis (SCORAD) index. Score goes from 0 to 103. Higher scores indicate a worse outcome.
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Dermatological symptoms through Itch Severity Scale (ISS)
Self-reported dermatological symptoms through Itch Severity Scale. Score goes from 0 to 21. Higher scores indicate a worse outcome
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Dermatological symptoms through Dermatology Life Quality Index (DLQI)
Self-reported dermatological symptoms through Dermatology Life Quality Index (DLQI). Score goes from 0 to 20. Higher scores indicate worse outcomes.
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Short-Form Health Survey (SF-36)
Self-reported Short-Form Health Survey (SF-36) Quality of Life. Score goes from 0 to 100. Higher scores indicate a better outcome.
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Creatinine (mg/dL)
Creatinine (mg/dL) to assess renal function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Glomerular filtration rate (mL/min/1.73m2)
Glomerular filtration rate (mL/min/1.73m2) to assess renal function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Uric acid (mg/dL)
Uric acid (mg/dL) to assess renal function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Albuminuria (mg/L)
Albuminuria (mg/L) to assess renal function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Albumin/creatinine ratio
Albumin (mg/L)/creatinine (mg/dL) ratio; to assess renal function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Urine (mg/g)
Urine (mg/g) ratio; to assess renal function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Urinary pH
Urinary pH to assess renal function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Urine specific gravity (g/mL)
Urine specific gravity (g/mL) to assess renal function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Aspartate Aminotransferase, ASAT (U/L)
Aspartate Aminotransferase, ASAT (U/L) to assess hepatic function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Alanine Aminotransferase, ALAT (U/L)
Alanine Aminotransferase, ALAT (U/L) to assess hepatic function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Gamma-Glutamyl Transferase, GGT (U/L)
Gamma-Glutamyl Transferase, GGT (U/L) to assess hepatic function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Total Bilirubin (mg/dL)
Total Bilirubin (mg/dL) to assess hepatic function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Alkaline Phosphatase (U/L)
Alkaline Phosphatase (U/L) to assess hepatic function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Lactate Dehydrogenase (U/L)
Lactate Dehydrogenase (U/L) to assess hepatic function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Total Proteins (g/L)
Total Proteins (g/L) to assess hepatic function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Albumin (g/L)
Albumin (g/L) to assess hepatic function
Measured: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start23 Jun 2023
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- After signing the informed consent, participants start taking the standard dose of 4.2 mg of adiDAO®Veg three times a day for a period of 2 weeks (phase 1). If the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose (8.4 mg) (phase 2), and repeating the process of doubling doses (16.8 mg) (phase 3), 33.6 mg (phase 4), and 67.2 mg (phase 5).
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006558
- Sponsor's protocol ID
- HCB/2023/0345
- Acronym
- HCB/2023/0345
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Serum DAO activity, participant-reported adverse effects (AEs).
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetic Study Of Supplementation With The Enzyme Diamine Oxidase In Patients With Histamine Intolerance
- ClinicalTrials.gov ID
- NCT07006558
- Acronym / sponsor ID
- HCB/2023/0345 / HCB/2023/0345
- Conditions
- Histamine Intolerance
- Keywords
- diamine oxidase, histamine intolerance, safety, tolerability, pea sprout, diamine oxidase supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AB BiotekIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 5 Jun 2025 (actual)
- 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.
The present study was conducted to assess the safety and tolerability of five ascending doses of plant-based DAO enzyme supplement in subjects with symptoms of histamine intolerance.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- After signing the informed consent, participants start taking the standard dose of 4.2 mg of adiDAO®Veg three times a day for a period of 2 weeks (phase 1). If the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose (8.4 mg) (phase 2), and repeating the process of doubling doses (16.8 mg) (phase 3), 33.6 mg (phase 4), and 67.2 mg (phase 5).
| Arm | Type | Receives |
|---|---|---|
| Phase 1 (4.2 mg adiDAO®Veg) | Experimental | Dietary Supplement: Diamino OxidasePatients receive the standard dose of 4.2 mg of adiDAO®Veg three times a day for a period of 2 weeks. |
| Phase 2 (8.4 mg adiDAO®Veg) | Experimental | Dietary Supplement: Diamino OxidaseIf, after phase 1, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 8.4 mg of adiDAO®Veg three times a day. |
| Phase 3 (16.8 mg adiDAO®Veg) | Experimental | Dietary Supplement: Diamino OxidaseIf, after phase 2, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 16.8 mg of adiDAO®Veg three times a day. |
| Phase 4 (33.6 mg adiDAO®Veg) | Experimental | Dietary Supplement: Diamino OxidaseIf, after phase 3, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 33.6 mg of adiDAO®Veg three times a day. |
| Phase 5 (67.2 mg adiDAO®Veg) | Experimental | Dietary Supplement: Diamino OxidaseIf, after phase 4, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 67.2 mg of adiDAO®Veg three times a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recent history of 2 or more symptoms associated to histamine intolerance.
- Altered activity of plasmatic DAO enzyme and/or at least one genetic variants linked to DAO deficiency (rs10156191, rs1049742, rs1049793, rs2052129).
- Not having started a dietary intervention (low histamine diet or DAO supplementation) before the start of this study.
Key exclusion criteria (4 listed)
- Treatment with low-histamine diet and/or dietary DAO enzyme supplementation prior to the study.
- Pharmacological treatment with antibiotics or probiotic supplements within the last month prior to enrollment.
- Breast-feeding or pregnant women.
- Inability to provide informed consent.
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 |
|---|---|---|
| Diamino OxidaseThe investigational product is a dehydrated power of DAO enzyme from green pea (Pisum sativum L.) sprouts (adiDAO®Veg, DR Healthcare, S.L.U., Barcelona, Spain), with an enzymatic activity > 298 mU/g (> 14,500 kHDU/g). | Dietary supplement | Phase 1 (4.2 mg adiDAO®Veg), Phase 2 (8.4 mg adiDAO®Veg), Phase 3 (16.8 mg adiDAO®Veg), Phase 4 (33.6 mg adiDAO®Veg), Phase 5 (67.2 mg adiDAO®Veg) |
Primary outcome
Number of participants with treatment-related adverse events (AEs)
Time frame: At "day 14", "day 28", "day 42", "day 56" and "day 70".
Number of participants with treatment-related adverse events (AEs) experienced during the supplementation, assessed through a questionnaire.
Type of adverse effects (AEs)
Time frame: At "day 14", "day 28", "day 42", "day 56" and "day 70".
Symptoms of adverse effects (AEs) experienced during the supplementation, assessed through a questionnaire including the different body systems: gastrointestinal, CNS, respiratory, dermatological).
DAO enzymatic activity in serum using a radioextraction immunoassay
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
DAO enzymatic activity in serum (mU/mL) using a radioextraction immunoassay (REA-3H, Laboratorio Echevarne, Barcelona, Spain).
38 secondary outcomes
Dietary habits
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Histamine in 24h urine
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Hemogram
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Glycemia
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
HbA1c
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Ionogram
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Lipid profile
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
C-reactive protein
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Interleukin-6
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Proteinuria
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Urine sediment
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Gastrointestinal symptoms through Rome IV criteria
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Gastrointestinal symptoms through Bristol Stool Scale
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Gastrointestinal symptoms through Gastrointestinal Quality of Life Index (GIQLI)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Headaches symptoms through MIDAS questionnaire
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Headaches symptoms through HIT-6 questionnaire
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Respiratory symptoms through SNOT-22 questionnaire
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Respiratory symptoms through Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Score goes from 0 to 6. Higher scores indicate a worse outcome.
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Dermatological symptoms through SCORAD index
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Dermatological symptoms through Itch Severity Scale (ISS)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Dermatological symptoms through Dermatology Life Quality Index (DLQI)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Short-Form Health Survey (SF-36)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Creatinine (mg/dL)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Glomerular filtration rate (mL/min/1.73m2)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Uric acid (mg/dL)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Albuminuria (mg/L)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Albumin/creatinine ratio
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Urine (mg/g)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Urinary pH
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Urine specific gravity (g/mL)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Aspartate Aminotransferase, ASAT (U/L)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Alanine Aminotransferase, ALAT (U/L)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Gamma-Glutamyl Transferase, GGT (U/L)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Total Bilirubin (mg/dL)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Alkaline Phosphatase (U/L)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Lactate Dehydrogenase (U/L)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Total Proteins (g/L)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Albumin (g/L)
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
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 18 Jun 2025.
- Individual participant dataSharing planned: Yes. Serum DAO activity, participant-reported adverse effects (AEs).
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diamino Oxidase in people with Histamine Intolerance, run by AB Biotek at 1 site in Spain.
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 3 inclusion and 4 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 18 Jun 2025. 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 Spain. 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?
Number of participants with treatment-related adverse events (AEs) (time frame: At "day 14", "day 28", "day 42", "day 56" and "day 70".). The study lists 3 primary outcomes in all. 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 18 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.