Treatment of Histamine Intolerance Using Probiotic Intervention - a Randomized Controlled Trial in Adults With Clinical Signs of Histamine Intolerance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Irritable bowel severity scoring system (IBS-SSS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Intervention
Participants receive Probio Histamed® (Lactopia GmbH), a 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.
干预措施: Probio Histamed®, a multi-species probiotic preparation containing Bifid. breve, Bifid. lactis, Bifid. infantis, Bifid. longum, Lact. gasseri, and Lact. rhamnosus (5 x 10⁹ CFU per day) (Dietary Supplement)
Control
Participants receive a placebo powder containing maltodextrin, identical in appearance and administration to the probiotic product.
The placebo is administered as 2 g per day dissolved in a cold or warm beverage and taken once daily before a meal for four weeks.
干预措施: Placebo Control (Other)
结局指标
主要结局
Irritable bowel severity scoring system (IBS-SSS)
时间窗: From baseline to the end of the study (4 weeks)
Chang of total score of IBS-SSS, a score ranging from 0 to 500. High values mean high gastrointestinal symptoms.
次要结局
- Facial flushing(From baseline to the end of the study (4 weeks))
- Itching(From baseline to the end of the study (4 weeks))
- Headache(From baseline to the end of the study (4 weeks))
- Dizziness(From baseline to the end of the study (4 weeks))
研究者
Stephan C. Bischoff, MD, Professor
MD, Professor
University of Hohenheim