Treatment of Histamine Intolerance Using Probiotic Intervention

NCT07397962 | Completed

• 1 other identifier: ZKES-HistaProbi-2023
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Histamin Intolerance

Keywords

Probiotics; Digestive symptoms; gut health; microbiome

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• 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)

Other Outcomes (2)

• 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)

Study Arms (2)

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.

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.

Other: Placebo Control

Interventions

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.

Intervention

Placebo Control OTHER

maltodextrin

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Hohenheim: lead
• Lactopia GmbH, An der Römerbrücke 16, 66121 Saarbrücken, Germany: collaborator

Study Sites (1)

Zentrum für klinische Ernährung Stuttgart

Stuttgart, 70599, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 9, 2026
• Study Start: May 2, 2024
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)