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| Name | Class |
|---|---|
| Lactopia GmbH, An der Römerbrücke 16, 66121 Saarbrücken, Germany | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to the end of the study (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Facial flushing | Facial flushing is measured on a visual analogue scale ranging from 0 to 100 with higher values meaning more pronounced symptoms. | From baseline to the end of the study (4 weeks) |
| Itching |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Diaminooxidase in capillary blood | From baseline to the end of the study (4 weeks) | |
| Concentration of Methylhistamine in urine | From baseline to the end of the study (4 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum für klinische Ernährung Stuttgart | Stuttgart | 70599 | Germany |
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| Placebo Control | Other | maltodextrin |
|
Itching is measured on a visual analogue scale ranging from 0 to 100 with higher values meaning more pronounced symptoms.
| From baseline to the end of the study (4 weeks) |
| Headache | Headache is measured on a visual analogue scale ranging from 0 to 100 with higher values meaning more pronounced symptoms. | From baseline to the end of the study (4 weeks) |
| Dizziness | Dizziness is measured on a visual analogue scale ranging from 0 to 100 with higher values meaning more pronounced symptoms. | From baseline to the end of the study (4 weeks) |