Treatment of Histamine Intolerance Using Probiotic Intervention (NCT07397962) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Histamine Intolerance Using Probiotic Intervention
Germany54 participantsStarted 2024-05-02
Plain-language summary
The goal of this clinical trial is to learn if a probiotic product can lower symptoms in adults with histamine intolerance. Histamine intolerance can cause stomach and bowel problems as well as symptoms such as flushing, itching, headaches, and dizziness. The study will also learn how safe and well tolerated the probiotic is.
The main questions this study aims to answer are:
Does the probiotic lower digestive symptoms linked to histamine intolerance?
Does it lower other common symptoms, such as flushing, itching, headaches, or dizziness?
Researchers will compare the probiotic to a placebo. A placebo is a look-alike powder that contains no active bacteria. This will help determine whether the probiotic works better than no treatment.
Participants will:
Take either the probiotic or the placebo once a day for four weeks
Visit the study center for screening and two study visits
Answer symptom questionnaires
Provide blood samples and urine samples
The study is for adults with symptoms of histamine intolerance. Participation is voluntary, and participants can stop taking part at any time.
Who can participate
Age range
18 Years – 70 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:
* Signed consent form
* Symptoms of histamine intolerance (based on medical history)
* DAO \< 10 U/mL
* Age 18-70 years
* Willingness to refrain from changing eating habits and physical activity during the study
* Sufficient understanding of the German language and sufficient mental state to understand information and instructions related to the study
Exclusion Criteria:
* Lactose intolerance
* Fructose malabsorption
* Helicobacter pylori infection
* Celiac disease
* Chronic inflammatory bowel disease
* Food allergy with gastrointestinal manifestation
* Mastocytosis
* Use of antihistamines
* Other gastrointestinal diseases or use of gastrointestinal medications, as determined by the investigator
* (Planned) change in current medication, as determined by the investigator
* Pregnancy and breastfeeding
* Inability to take the investigational drug orally
* Intolerance to the investigational drug
* Admission to a clinic or similar facility due to official or court order
* Participation in another clinical trial (currently or within the last 30 days prior to study start)
* A health condition or regular medication use that, in the opinion of the investigator, does not allow participation in the study or the evaluation of study parameters or the consumption of the investigational drug (individual decision)
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
1
Irritable bowel severity scoring system (IBS-SSS)
Timeframe: From baseline to the end of the study (4 weeks)