Histamin IntoleranceNCT07397962
Treatment of Histamine Intolerance Using Probiotic Intervention
A study testing 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) in people with Histamin Intolerance, run by University of Hohenheim at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Histamin Intolerance
- What is being tested?
- 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)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2024to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lactose intolerance
- Fructose malabsorption
- Helicobacter pylori infection
- Celiac disease
- Chronic inflammatory bowel disease
- Food allergy with gastrointestinal manifestation
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Histamine Intolerance Using Probiotic Intervention - a Randomized Controlled Trial in Adults With Clinical Signs of Histamine Intolerance
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:
Read more
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.
- Conditions
- Histamin Intolerance
- Being tested
- 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), Placebo Control
- Keywords
- Probiotics, Digestive symptoms, gut health, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo ControlOther
maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
| 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. Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to the end of the study (4 weeks)
Secondary outcomes (4)
Facial flushing
Facial flushing is measured on a visual analogue scale ranging from 0 to 100 with higher values meaning more pronounced symptoms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of the study (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start2 May 2024
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histamin IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- Lactopia GmbH, An der Römerbrücke 16, 66121 Saarbrücken, Germany
- Responsible party
- Principal investigator, Stephan C. Bischoff, MD, Professor, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397962
- Sponsor's protocol ID
- ZKES-HistaProbi-2023
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Histamine Intolerance Using Probiotic Intervention - a Randomized Controlled Trial in Adults With Clinical Signs of Histamine Intolerance
- ClinicalTrials.gov ID
- NCT07397962
- Acronym / sponsor ID
- ZKES-HistaProbi-2023
- Conditions
- Histamin Intolerance
- Keywords
- Probiotics, Digestive symptoms, gut health, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- Lactopia GmbH, An der Römerbrücke 16, 66121 Saarbrücken, Germany
- Study start
- 2 May 2024 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | 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 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 | Other: Placebo ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- Lactose intolerance
- Fructose malabsorption
- Helicobacter pylori infection
- Celiac disease
- Chronic inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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)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 | Intervention |
| Placebo Controlmaltodextrin | Other | Control |
Primary outcome
Irritable bowel severity scoring system (IBS-SSS)
Time frame: 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.
4 secondary outcomes
Facial flushing
Time frame: From baseline to the end of the study (4 weeks)
Itching
Time frame: From baseline to the end of the study (4 weeks)
Headache
Time frame: From baseline to the end of the study (4 weeks)
Dizziness
Time frame: From baseline to the end of the study (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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) in people with Histamin Intolerance, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable bowel severity scoring system (IBS-SSS) (time frame: From baseline to the end of the study (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.