Could a probiotic ease histamine intolerance symptoms?
NCT ID NCT07397962
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a probiotic supplement can reduce symptoms of histamine intolerance in adults. Fifty-four participants took either the probiotic or a placebo daily for four weeks. Researchers measured changes in digestive issues, flushing, itching, and headaches to see if the probiotic helped.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Probio Histamed® (a mix of Bifidobacterium and Lactobacillus bacteria)
- What this could lead to
- If it works, this could point toward a simple, natural way to manage histamine intolerance symptoms like stomach pain, flushing, and headaches.
- What could go wrong
- This is a small, completed trial with only 54 participants. The results may not apply to everyone, and the probiotic might not work better than a placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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54 people
The number who actually took part.
- Started
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May 2024
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Zentrum für klinische Ernährung Stuttgart
Stuttgart, 70599, Germany