Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Lactobacillus reuteri, dyspeptic patients, eradication
Brief summary
Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.
Detailed description
Helicobacter pylori (H. Pylori) infection is a wide spread disease and is endemic in many countries including Egypt with a wide range of morbidity; that requires appropriate antimicrobial therapy . However, worldwide the eradication rate following the standard triple therapy is declining and this may necessitates introduction of new antimicrobial agents . On the sight of bearing in vivo and in vitro activity against H. Pylori, the use of different strains of probiotics in treatment of H. Pylori may be thus justifiable, Lactobacillus reuteri (L. reuteri) which through different mechanisms including production of reuterin have anti H.pylori activity have been tried in improving the eradication rates of H.pylori with contradictory results . This study is conducted to test the assumption that addition of L. reuteri to the standard triple therapy in treatment of H. Pylori improves the eradication rates and clinical aspects in H. Pylori infection.
Interventions
DIETARY_SUPPLEMENTLactobacillus reuteri
Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.
DIETARY_SUPPLEMENTPlacebo
Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.
DRUGOmeprazole
All patients will receive omeprazole 20 mg b.i.d for 2 week
DRUGAmoxicillin
amoxicillin 1000 mg b.i.d for 2 weeks
DRUGClarithromycin
clarithromycin 500mg b.i.d for 2 weeks
Sponsors
BioGaia AB
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Inclusion of patients with these criteria 1. Age: 18-60 years 2. Any sex 3. Confirmed H. Pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or H. Pylori antigen in stool 4. Good mentality to understand aim, benefits and steps of the study 5. Assumed availability during the study period 6. Written informed consent
Exclusion criteria
* Exclusion of 1. Patients with chronic diseases e.g. diabetes, renal failure, cirrhosis…etc. 2. Patients with malignancy. 3. Patients with gall bladder disorders. 4. Patients with peptic ulcer. 5. Patients with prior upper GIT surgery. 6. Patients with probiotics therapy in the last one month. 7. Patients with triple therapy, antibiotics, proton pump inhibitors and H2 receptor blockers therapy within one month. 8. Patients with known allergy to the used medications \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication of H Pylori Infection 4 Weeks After Completion of Therapy | 4 weeks therapy | H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe Adverse Effects to the Used Medications and Dietary Supplements. | 4 weeks | — |
| The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. | 8 weeks | Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them. |
Countries
Egypt
Participant flow
Recruitment details
All adult dyspeptic patients presented to outpatient gastroenterology clinics of the Tropical Medicine and Internal Medicine Departments, Faculty of Medicine, Zagazig University Hospitals, Egypt from June 2012 to February 2013 were offered to share in the study
Participants by arm
| Arm | Count |
|---|---|
| Lactobacillus Reuteri Group The active group that will receive the standard triple therapy and Lactobacillus reuteri | 35 |
| Control Group The control group that will receive the standard triple therapy and placebo | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Total | Control Group | Lactobacillus Reuteri Group |
|---|---|---|---|
| ِAge | 35.00 years STANDARD_DEVIATION 12.65 | 36.80 years STANDARD_DEVIATION 11.085 | 33.20 years STANDARD_DEVIATION 13.974 |
| Age, Continuous | 35.00 years | 36.80 years | 33.20 years |
| Sex: Female, Male Female | 46 Participants | 24 Participants | 22 Participants |
| Sex: Female, Male Male | 24 Participants | 11 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 35 | 25 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Eradication of H Pylori Infection 4 Weeks After Completion of Therapy
H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.
Time frame: 4 weeks therapy
Population: It is assessment of all the 70 participants about H pylori eradication status
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Eradication of H Pylori Infection 4 Weeks After Completion of Therapy | 23 participants |
| Lactobacillus Reuteri Group | Eradication of H Pylori Infection 4 Weeks After Completion of Therapy | 26 participants |
Secondary
Severe Adverse Effects to the Used Medications and Dietary Supplements.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Severe Adverse Effects to the Used Medications and Dietary Supplements. | 0 percentage of participants |
| Lactobacillus Reuteri Group | Severe Adverse Effects to the Used Medications and Dietary Supplements. | 0 percentage of participants |
Comparison: A total of 70 patients were included; 35 in each arm. The sample size was calculated assuming eradication of H. pylori in at least 70% of treated patients, aiming to detect a difference of 30% based on a 0.80 power to detect significant difference (p =0.05, two-sided).
Secondary
The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.
Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. | 0 participants |
| Lactobacillus Reuteri Group | The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. | 0 participants |