Treatment of Histamine Intolerance Using Probiotic Intervention

University of Hohenheim54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Histamin Intolerance

Interventions

Multi-species probiotic preparation containing Bifidobacterium breve, Bifidobacterium lactis, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus gasseri, and Lactobacillus rhamnosus (total dose 5 × 10⁹ CFU per day). The product is administered as a powder (2 g per day) dissolved in a cold or warm beverage and taken once daily before a meal for four weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Irritable bowel severity scoring system (IBS-SSS)

Chang of total score of IBS-SSS, a score ranging from 0 to 500. High values mean high gastrointestinal symptoms.