Supplementation With L. Reuteri in H. Pylori Infected Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Lama Medical Care s.r.o..
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Lama Medical Care s.r.o.
ClinicalTrials.gov Identifier:
NCT01449500
First received: October 6, 2011
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

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 Intervention
Dyspepsia
H. Pylori Infection
Dietary Supplement: L. reuteri
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Lama Medical Care s.r.o.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: October 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
Chewable tablet, one tablet per day for 28 days
Other Name: Placebo
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449500

Contacts
Contact: Ladislav Kuzela, MD +42 1257 108 511 kuzela@thalion.sk

Locations
Slovakia
Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5 Not yet recruiting
Bratislava, Slovakia, 81107
Contact: Barbora Zacharova, Dr       zacharova@thalion.sk   
Sponsors and Collaborators
Lama Medical Care s.r.o.
BioGaia AB
Investigators
Principal Investigator: Ladislav Kuzela, MD Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5, 811 07, Bratislava, Slovakia
  More Information

No publications provided

Responsible Party: Lama Medical Care s.r.o.
ClinicalTrials.gov Identifier: NCT01449500     History of Changes
Other Study ID Numbers: CSUB0028
Study First Received: October 6, 2011
Last Updated: October 7, 2011
Health Authority: Slovak Republic: Ethics Committee

Keywords provided by Lama Medical Care s.r.o.:
Dyspeptic H.pylori-infection

Additional relevant MeSH terms:
Dyspepsia
Helicobacter Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014