CompletedNot Applicable

Kinetic Study Of Supplementation With The Enzyme Diamine Oxidase In Patients With Histamine Intolerance

Spain15 participantsStarted 2023-06-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of participants with treatment-related adverse events (AEs)

Timeframe: At "day 14", "day 28", "day 42", "day 56" and "day 70".

Type of adverse effects (AEs)

Timeframe: At "day 14", "day 28", "day 42", "day 56" and "day 70".

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".

Trial details

NCT IDNCT07006558

SponsorAB Biotek

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-05

View on ClinicalTrials.gov More Histamine Intolerance trials