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
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