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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01593592 |
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Date of registration:
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05/05/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients
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Scientific title:
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Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients: a Double Blind Placebo Controlled Randomized Clinical Trial |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01593592 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Egypt
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Helicobacter Pylori Infection
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Intervention(s)
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Dietary Supplement: Placebo
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Drug: Amoxicillin
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Drug: Clarithromycin
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Dietary Supplement: Lactobacillus reuteri
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Drug: Omeprazole
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Primary Outcome(s)
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Eradication of H Pylori Infection 4 Weeks After Completion of Therapy
[Time Frame: 4 weeks therapy]
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Secondary Outcome(s)
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Severe Adverse Effects to the Used Medications and Dietary Supplements.
[Time Frame: 4 weeks]
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The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.
[Time Frame: 8 weeks]
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Secondary ID(s)
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IRB#:395/29-4-2012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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