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| ID | Type | Description | Link |
|---|---|---|---|
| IRB#:395/29-4-2012 | Other Identifier | Zagazig University |
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| Name | Class |
|---|---|
| BioGaia AB | INDUSTRY |
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Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus reuteri group | Experimental | The active group that will receive the standard triple therapy and Lactobacillus reuteri |
|
| Control group | Placebo Comparator | The control group that will receive the standard triple therapy and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Inclusion of patients with these criteria
Exclusion Criteria:
Exclusion of
Patients with chronic diseases e.g. diabetes, renal failure, cirrhosis…etc.
Patients with malignancy.
Patients with gall bladder disorders.
Patients with peptic ulcer.
Patients with prior upper GIT surgery.
Patients with probiotics therapy in the last one month.
Patients with triple therapy, antibiotics, proton pump inhibitors and H2 receptor blockers therapy within one month.
Patients with known allergy to the used medications
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University Hospitals | Zagazig | Sharqia Province | 44519 | Egypt |
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| Label | URL |
|---|---|
| Study location Hospital | View source |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | The control group that will receive the standard triple therapy and placebo Placebo : 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. |
| FG001 | Lactobacillus Reuteri Group | The active group that will receive the standard triple therapy and Lactobacillus reuteri Lactobacillus 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All were dyspeptic patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Lactobacillus Reuteri Group | The active group that will receive the standard triple therapy and Lactobacillus reuteri |
| BG001 | Control Group | The control group that will receive the standard triple therapy and placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | It is assessment of all the 70 participants about H pylori eradication status | Posted | Number | participants | 4 weeks therapy |
|
8 weeks
Patients were followed up for 8 weeks to report any adverse events and side effects
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lactobacillus Reuteri Group | The active group that will receive the standard triple therapy and Lactobacillus reuteri Lactobacillus 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Galactorrhea | Reproductive system and breast disorders | Non-systematic Assessment | one virgin female patient developed galactorrhea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mohamed Emara | Tropical Medicine Departement, Faculty of Medicine, Zagazig University, Egypt | +2 0100 272 4482 | emara_20007@yahoo.com |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Placebo | Dietary Supplement | 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. |
|
| Omeprazole | Drug | All patients will receive omeprazole 20 mg b.i.d for 2 week |
|
| Amoxicillin | Drug | amoxicillin 1000 mg b.i.d for 2 weeks |
|
| Clarithromycin | Drug | clarithromycin 500mg b.i.d for 2 weeks |
|
| 8 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ِAge | It is a measure of age from 18 to 60 years old for participants | Mean | Standard Deviation | years |
|
| Lactobacillus Reuteri Group |
The active group that will receive the standard triple therapy and Lactobacillus reuteri Lactobacillus 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. |
|
|
| Secondary | Severe Adverse Effects to the Used Medications and Dietary Supplements. | Posted | Number | percentage of participants | 4 weeks |
|
|
|
|
| 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. | Posted | Number | participants | 8 weeks |
|
|
|
| 0 |
| 35 |
| 10 |
| 35 |
| EG001 | Control Group | The control group that will receive the standard triple therapy and placebo Placebo: 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. | 0 | 35 | 25 | 35 |
|
| Taste disorders | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |