Supplementation With L. Reuteri in H. Pylori Infected Adults

Dyspepsia Clinical Trial

Official title:

Effect of Dietary Supplementation With L. Reuteri ProGastria in H. Pylori-infected Adult Subjects Treated Only With Proton Pump Inhibitors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01449500
• Other study ID #: CSUB0028
• Status: Not yet recruiting
• Phase: N/A
• First received: October 6, 2011
• Last updated: October 7, 2011
• Start date: October 2011
• Est. completion date: April 2012

Study information

• Verified date: October 2011
• Source: Lama Medical Care s.r.o.
• Contact: Ladislav Kuzela, MD
• Phone: +42 1257 108 511
• Email: kuzela[@]thalion.sk
• Is FDA regulated: No
• Health authority: Slovak Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dyspepsia
• H. Pylori Infection
• Helicobacter Infections

Intervention

Dietary Supplement:
• L. reuteri
Chewable tablet, one tablet/day for 28 days
• Placebo
Chewable tablet, one tablet per day for 28 days

Locations

Country	Name	City	State
Slovakia	Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5	Bratislava

Sponsors (2)

Lead Sponsor	Collaborator
Lama Medical Care s.r.o.	BioGaia AB

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in the number of subjects with treatment success after 28 days of treatment with omeprazole + L. reuteri compared to those given omeprazole + placebo.	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.	28 days	No
Secondary	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		3 months	No