Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Supplementation With L. Reuteri in H. Pylori Infected Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01449500
Recruitment Status : Unknown
Verified October 2011 by Lama Medical Care s.r.o..
Recruitment status was:  Not yet recruiting
First Posted : October 10, 2011
Last Update Posted : October 10, 2011
BioGaia AB
Information provided by (Responsible Party):
Lama Medical Care s.r.o.

Brief Summary:
To determine whether simultaneous use of L. reuteri ProGastria and proton pump inhibitors can eradicate H. pylori in humans in the absence of antibiotics.

Condition or disease Intervention/treatment Phase
Dyspepsia H. Pylori Infection Dietary Supplement: L. reuteri Dietary Supplement: Placebo Not Applicable

Detailed Description:

Fifty-six (56) subjects, aged 18-70 years will be recruited from patients with dyspeptic symptoms referred to the clinic for consultation about H. pylori infection and who have not previously been treated for this infection. Patients in whom H. pylori infection is confirmed (by endoscopy with biopsy) and who fulfil the inclusion criteria, will be invited to enter the study. After written consent has been obtained subjects will be randomly allocated to one of two groups, one to receive omeprazole (2x20mg/day) + 1 tablet placebo per day and the other to receive omeprazole (2x20mg/day) + 1 tablet (2x108 CFU L. reuteri) ProGastria per day.

After randomisation on Day 0 of the study, the subjects will also be asked to complete a gastrointestinal symptom rating score (GSRS) to determine baseline symptomology.

Intervention will begin on Day 1 and last for 28 days after which therapy will be stopped. The subjects will be asked to complete the GSRS questionnaire on Day 14 and Day 28. At Day 14, the patients GSRS scores are monitored and the patients interviewed. In those patients where there is a marked deterioration of their condition or symptoms, these will be considered treatment failures and eradication therapy will then be started on Day 15.

The day after therapy is stopped (Day 29), patients symptoms will be assessed. All patients will undergo gastroscopy to determine the presence of H. pylori or not. If H. pylori infection is confirmed (by endoscopy and biopsy staining), these subjects will be given triple therapy to eradicate the infection and followed up on Day 90 of the study.

On Day 29, those patients that no longer complain of symptoms and are shown to be free of H. pylori infection by endoscopy (treatment success group), will continue with no further therapy until Day 90.

On Day 90 all subjects will be given a UBT to determine the presence of H. pylori infection and symptoms will be again assessed using GSRS. Asymptomatic patients with negative breath test will be considered recovered. In those patients where persistent H. pylori infection is confirmed by breath test, second line therapy will be implemented as indicated.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Dietary Supplementation With L. Reuteri ProGastria in H. Pylori-infected Adult Subjects Treated Only With Proton Pump Inhibitors
Study Start Date : October 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Arm Intervention/treatment
Placebo Comparator: Placebo
Dietary Supplement: Placebo
Chewable tablet, one tablet per day for 28 days

Active Comparator: L. reuteri

L. reuteri will be delivered at a dose of 1x108 CFU of each strain of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day.

Intervention: Dietary Supplement: L. reuteri DSM 17938 and ATCC PTA 6475

Dietary Supplement: L. reuteri
Chewable tablet, one tablet/day for 28 days
Other Name: L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475

Primary Outcome Measures :
  1. Increase in the number of subjects with treatment success after 28 days of treatment with omeprazole + L. reuteri compared to those given omeprazole + placebo. [ Time Frame: 28 days ]
    Treatment success is defined as the absence of H. pylori infection as shown by a significant reduction in symptoms on Day 28 and by the absence of H. pylori on gastric biopsy at Day 28.

Secondary Outcome Measures :
  1. Fewer patients in the L. reuteri treatment success group with demonstrated presence of H. pylori infection, measured as UBT on Day 90 compared to the placebo treatment success group [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects aged 18-70 years
  • Infection with H. pylori defined by endoscopic examination with biopsy H. pylori staining
  • Non-ulcer dyspepsia
  • Absence of other pathology as shown by basic clinical laboratory tests (blood and urine) as well as abdominal ultrasound
  • No earlier eradication therapy for H. pylori infection
  • Written informed consent
  • Stated availability throughout the entire study period
  • Mental ability to understand and willingness to fulfil all the details of the protocol.

Exclusion Criteria:

  • Duodenal or gastric ulcer
  • MALT lymphoma
  • Gastric resection (at any time)
  • First level relatives of gastric cancer patients
  • Absence of GI symptoms
  • Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasional use) or 3 weeks (for chronic use) of inclusion
  • Use of oral antibiotics and/or PPIs and/or H2-antagonists during the 2 weeks prior to ingestion of the study product
  • Pregnancy
  • Participation in other clinical trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01449500

Layout table for location contacts
Contact: Ladislav Kuzela, MD +42 1257 108 511

Layout table for location information
Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5
Bratislava, Slovakia, 81107
Contact: Barbora Zacharova, Dr   
Sponsors and Collaborators
Lama Medical Care s.r.o.
BioGaia AB
Layout table for investigator information
Principal Investigator: Ladislav Kuzela, MD Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5, 811 07, Bratislava, Slovakia

Layout table for additonal information
Responsible Party: Lama Medical Care s.r.o. Identifier: NCT01449500    
Other Study ID Numbers: CSUB0028
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: October 10, 2011
Last Verified: October 2011
Keywords provided by Lama Medical Care s.r.o.:
Dyspeptic H.pylori-infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Digestive
Signs and Symptoms