Kinetic Study Of Supplementation With The Enzyme Diamine Oxidase In Patients With Histamine Intolerance (HCB/2023/0345)

AB Biotek

Status: Completed

Conditions: Histamine Intolerance

Treatments: Dietary Supplement: Diamino Oxidase

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07006558

HCB/2023/0345

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 5 patient groups

Phase 1 (4.2 mg adiDAO®Veg)

Experimental group

Description:

Patients receive the standard dose of 4.2 mg of adiDAO®Veg three times a day for a period of 2 weeks.

Treatment:

Dietary Supplement: Diamino Oxidase

Phase 2 (8.4 mg adiDAO®Veg)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Diamino Oxidase

Phase 3 (16.8 mg adiDAO®Veg)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Diamino Oxidase

Phase 4 (33.6 mg adiDAO®Veg)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Diamino Oxidase

Phase 5 (67.2 mg adiDAO®Veg)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Diamino Oxidase