Control of Helicobacter pylori by a specific strain of Lactobacillus reuteri

In-vivo cross-over study to test impact of a specific strain of Lactobacillus reuteri (DSMZ17648 (Pylopass™ / Lonza) on infection by Helicobacter pylori as determined by 13C urea breath test

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70607306

Enrollment

Registered

2012-08-30

Start date

2011-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori Infections and Infestations Helicobacter pylori [H.pylori] as the cause of diseases classified

Interventions

Lactobacillus reuteri (DSMZ17648 (Pylopass™ / Lonza) vs placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years 2. Male and female participants 3. Infection by H.pylori with by 13C urea breath test =12

Exclusion criteria

Exclusion criteria: 1. Intake of any medication interfering with the action of the lactobacilli 2. Previous surgical procedures affecting stomach or small intestine with potential interference with the study, e.g. gastrectomy or gastric bypass, diabetes type 1 or 2 3. Familiar lipid metabolism diseases, liver disease, kidney insufficiency, autoimmune disease, organ transplantation 4. Weight changes >3 kg over the last 3 months 5. Eradication therapy 6. Lactose intolerance 7. Oral intake of antibiotics < 3 months ago 8. Intake of PPIs or H2 antagonists 9. Pregnancy or lactation 10. Alcohol or drug abuse 11. Psychiatric diseases 12. Participation at other clinical trials at the same time

Design outcomes

Primary

Measure	Time frame
13C urea breath test is a semi-quantitative test for infection by H.pylori. Breath samples are taken before treatment, after 2 weeks of active treatment, and after two weeks of placebo. Samples are sent to a commercial lab for analysis.	—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026