Condition category
Infections and Infestations
Date applied
22/08/2012
Date assigned
30/08/2012
Last edited
10/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Infection with H. pylori bacteria is the cause of most stomach ulcers. The management of H. pylori infections is still a matter of discussion. Treatment options for H. pylori aiming at complete eradication of the infection include various combinations of proton pump inhibitor drugs combined with two to three antibiotics. This complex approach has high risks of side effects and patient non-compliance with the treatment. As there can be an interaction between H. pylori infections and mental stress, short-term reduction of the infection may be another viable option during stressful life events. This study will test whether supplementation with Lactobacillus reuteri bacteria decreases H. pylori infection.

Who can participate?
Men and women between the ages of 18 and 75 with an H. pylori infection.

What does the study involve?
Participants will be tested to find out whether they have antibodies against H.pylori. If they do, their infection state will be diagnosed by a breath test. If this test confirms an ongoing infection and no acute diseases or other potential reasons for exclusion from the study, participants will take tablets containing either dried Lactobacillus reuteri or a placebo (dummy) tablet, each for two weeks. After each two-week period, the breath test will be repeated.

What are the possible benefits and risks of participating?
If the Lactobacillus reuteri tablets reduce H.pylori infection, there may be a short-term benefit for participants. This does not mean an eradication of the H.pylori infection. There are no known risks related to the test product or the diagnostic procedures.

Where is the study run from?
University Hospital Charité in Berlin-Buch, under coordination from HealthTwist GmbH.

When is the study starting and how long is it expected to run for?
The study ran from September 2011 to September 2012.

Who is funding the study?
Lonza Ltd (Switzerland).

Who is the main contact?
Dr Andreas Busjahn
info@healthtwist.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andreas Busjahn

ORCID ID

Contact details

HealthTwiSt GmbH
Lindenberger Weg 80
Berlin
13125
Germany
busjahn@healthtwist.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

Reduction of H. pylori load as measured by 13C-UBT after two weeks of Pylopass™ supplementation.

Ethics approval

Ethics committee of Charité, Berlin, 12/09/2011, ref: EA3/017/07

Study design

Single-center non-randomized interventional placebo-controlled cross-over study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Helicobacter pylori

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

No secondary outcome measures

Overall trial start date

01/09/2011

Overall trial end date

01/10/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

01/09/2011

Recruitment end date

01/10/2012

Locations

Countries of recruitment

Germany

Trial participating centre

HealthTwiSt GmbH
Berlin
13125
Germany

Sponsor information

Organisation

Lonza Ltd (Switzerland)

Sponsor details

Scientific Marketing
Nutrition
Münchensteinerstrasse 38
Basel
4002
Switzerland

Sponsor type

Industry

Website

http://www.lonza.com/

Funders

Funder type

Industry

Funder name

Lonza Ltd (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes