N/A
N=70
Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients
Helicobacter Pylori Infection
Bottom Line
View on ClinicalTrials.gov: NCT01593592 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Eradication of H Pylori Infection 4 Weeks After Completion of Therapy — 23; 26 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lactobacillus reuteri (Dietary_supplement); Placebo (Dietary_supplement); Omeprazole (Drug); Amoxicillin (Drug); Clarithromycin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zagazig University
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eradication of H Pylori Infection 4 Weeks After Completion of Therapy |
23; 26 | — |
| SECONDARY Severe Adverse Effects to the Used Medications and Dietary Supplements. |
0; 0 | — |
| SECONDARY The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. |
0; 0 | — |
Summary
Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.
Eligibility Criteria
Inclusion Criteria
Inclusion of patients with these criteria
- Age: 18-60 years
- Any sex
- Confirmed H. Pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or H. Pylori antigen in stool
- Good mentality to understand aim, benefits and steps of the study
- Assumed availability during the study period
- Written informed consent
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
-
Data sourced from ClinicalTrials.gov (NCT01593592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.