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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

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".