Clinical trial NCT01449500: Supplementation With L. Reuteri in H. Pylori Infected Adults
Official title: Effect of Dietary Supplementation With L. Reuteri ProGastria in H. Pylori-infected Adult Subjects Treated Only With Proton Pump Inhibitors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyspepsia
H. Pylori Infection
Keywords: Dyspeptic H.pylori-infection
Lead sponsor: Lama Medical Care s.r.o.
Sponsor class: INDUSTRY
Collaborators: name: BioGaia AB
First posted: 2011-10-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase in the number of subjects with treatment success after 28 days of treatment with omeprazole + L. reuteri compared to those given omeprazole + placebo.
timeFrame: 28 days
Secondary outcomes:
measure: 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
timeFrame: 3 months
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5
Study officials:
affiliation: Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5, 811 07, Bratislava, Slovakia
name: Ladislav Kuzela, MD
role: PRINCIPAL_INVESTIGATOR
References: