MedTrace Logo

Treatment of Histamine Intolerance Using Probiotic Intervention

NCT07397962 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-02-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lactopia GmbH, An der Römerbrücke 16, 66121 Saarbrücken, Germany

    collaborator UNKNOWN

  • University of Hohenheim

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-02
Primary Completion
2025-07-25
Completion
2025-07-25

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07397962 on ClinicalTrials.gov