Supplementation With L. Reuteri in H. Pylori Infected Adults
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia H. Pylori Infection||Dietary Supplement: L. reuteri Dietary Supplement: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|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|
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
- 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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449500
|Contact: Ladislav Kuzela, MD||+42 1257 108 email@example.com|
|Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5||Not yet recruiting|
|Bratislava, Slovakia, 81107|
|Contact: Barbora Zacharova, Dr firstname.lastname@example.org|
|Principal Investigator:||Ladislav Kuzela, MD||Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5, 811 07, Bratislava, Slovakia|