Clinical trial NCT07006558: Kinetic Study Of Supplementation With The Enzyme Diamine Oxidase In Patients With Histamine Intolerance
Official title: Kinetic Study Of Supplementation With The Enzyme Diamine Oxidase In Patients With Histamine Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Histamine Intolerance
Keywords: diamine oxidase
histamine intolerance
safety
tolerability
pea sprout
diamine oxidase supplementation
Lead sponsor: AB Biotek
Sponsor class: INDUSTRY
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2025-06-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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).
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events (AEs)
timeFrame: At "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Type of adverse effects (AEs)
timeFrame: At "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: DAO enzymatic activity in serum using a radioextraction immunoassay
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Secondary outcomes:
measure: Dietary habits
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Histamine in 24h urine
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Hemogram
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Glycemia
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: HbA1c
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Ionogram
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Lipid profile
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: C-reactive protein
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Interleukin-6
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Proteinuria
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Urine sediment
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Gastrointestinal symptoms through Rome IV criteria
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Gastrointestinal symptoms through Bristol Stool Scale
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Gastrointestinal symptoms through Gastrointestinal Quality of Life Index (GIQLI)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Headaches symptoms through MIDAS questionnaire
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Headaches symptoms through HIT-6 questionnaire
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Respiratory symptoms through SNOT-22 questionnaire
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Respiratory symptoms through Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Score goes from 0 to 6. Higher scores indicate a worse outcome.
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Dermatological symptoms through SCORAD index
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Dermatological symptoms through Itch Severity Scale (ISS)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Dermatological symptoms through Dermatology Life Quality Index (DLQI)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Short-Form Health Survey (SF-36)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Creatinine (mg/dL)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Glomerular filtration rate (mL/min/1.73m2)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Uric acid (mg/dL)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Albuminuria (mg/L)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Albumin/creatinine ratio
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Urine (mg/g)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Urinary pH
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Urine specific gravity (g/mL)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Aspartate Aminotransferase, ASAT (U/L)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Alanine Aminotransferase, ALAT (U/L)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Gamma-Glutamyl Transferase, GGT (U/L)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Total Bilirubin (mg/dL)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Alkaline Phosphatase (U/L)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Lactate Dehydrogenase (U/L)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Total Proteins (g/L)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
measure: Albumin (g/L)
timeFrame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
References: