NCT07397962

Treatment of Histamine Intolerance Using Probiotic Intervention

Treatment of Histamine Intolerance Using Probiotic Intervention - a Randomized Controlled Trial in Adults With Clinical Signs of Histamine Intolerance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Hohenheim · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)	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.
OTHER	Placebo Control	maltodextrin

Timeline

• Start date: 2024-05-02
• Primary completion: 2025-07-25
• Completion: 2025-07-25
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Germany