Control of Helicobacter pylori by a specific strain of Lactobacillus reuteri
| ISRCTN | ISRCTN70607306 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70607306 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/08/2012
- Registration date
- 30/08/2012
- Last edited
- 10/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
HealthTwiSt GmbH
Lindenberger Weg 80
Berlin
13125
Germany
| busjahn@healthtwist.de |
Study information
| Study design | Single-center non-randomized interventional placebo-controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Reduction of H. pylori load as measured by 13C-UBT after two weeks of Pylopass™ supplementation. |
| Ethics approval(s) | Ethics committee of Charité, Berlin, 12/09/2011, ref: EA3/017/07 |
| Health condition(s) or problem(s) studied | Helicobacter pylori |
| Intervention | Lactobacillus reuteri (DSMZ17648 (Pylopass™ / Lonza) vs placebo |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/09/2011 |
| Completion date | 01/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 01/10/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
13125
Germany
Sponsor information
Industry
Scientific Marketing, Nutrition
Münchensteinerstrasse 38
Basel
4002
Switzerland
| Website | http://www.lonza.com/ |
|---|---|
"ROR" |
https://ror.org/002adfz67 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
