An interventional study of 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) and Placebo Control in Histamin Intolerance, sponsored by University of Hohenheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by University of Hohenheim · Not applicable, Interventional, and Treatment
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.
University of Hohenheim is the lead sponsor of 43 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: 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)
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.
Other: Placebo Control
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.
maltodextrin
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.
Time frame: From baseline to the end of the study (4 weeks)
Facial flushing
Facial flushing is measured on a visual analogue scale ranging from 0 to 100 with higher values meaning more pronounced symptoms.
Time frame: From baseline to the end of the study (4 weeks)
Itching
Itching is measured on a visual analogue scale ranging from 0 to 100 with higher values meaning more pronounced symptoms.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to the end of the study (4 weeks)
Concentration of Diaminooxidase in capillary blood
Time frame: From baseline to the end of the study (4 weeks)
Concentration of Methylhistamine in urine
Time frame: From baseline to the end of the study (4 weeks)
Plan to share: No
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of Hohenheim