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IRCT20141201020178N10 IRCT 2020-09-11 Iran University of Medical Sciences Lactobacillus reuteri Supplementation for Helicobacter pylori Eradication among Patients with Dyspepsia Lactobacillus reuteri Supplementation versus Standard Triple Therapy for Helicobacter pylori Eradication among Patients with Dyspepsia 2020-05-16 anticipated 80 Complete https://irct.ir/trial/48811 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is going to be carried out by block randomization, which works by randomizing participants within blocks such that an equal number is assigned to each group. Regarding this method, we will divide patients into two groups (male and female). Then we will provide six blocks which have a size of four, including: TCTC, TTCC, TCCT, ....... (T: Treatment, C: Control), and we will assign the patients of each group into these blocks so that we will have equal treatment and control in each group (male and female). 2-3 Condition 1: Functional dyspepsia. Condition 2: Helicobacter pylori. Intervention 1: Intervention group: Esomeperazole Cap 40 mg BD + Amoxicillin Cap 500 mg 2*BD + Clarithromycin Tab 500 mg BD + Pyloshot Tab for 10 days. Intervention 2: Control group: Esomeperazole Cap 40 mg BD + Amoxicillin Cap 500 mg 2*BD + Clarithromycin Tab 500 mg BD for 10 days. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure would be shared. When: It would be available 6 months after publication. To whom: This is only available for people working in academic institutions and/ or people working in businesses can also apply to receive it. Conditions: People working in academic institutions Where to obtain: Email address of corresponding author How to obtain: Up to three months after approval of ID documents Comments:
public Marjan Mokhtare
Rasul-e Akram Hospital, Niayesh St., Sattarkhan Ave., Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6735 2477 mokhtare.m@iums.ac.ir Iran University of Medical Sciences scientific Marjan Mokhtare
Rasul-e Akram Hospital, Niayesh St., Sattarkhan Ave., Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6735 2477 mokhtare.m@iums.ac.ir Rasul-e Akram Hospital Iran (Islamic Republic of) Patients aged between 18 to 70 years old with dyspepsia presentation H. Pylori documentation by antral biopsy (Rapid Urease Test or Giemsa staining) or Urea Breath Test 18 years 70 years Both Pregnancy or breast- feeding Women taking oral contraceptive pill (OCP) Significant underlying diseases such as cardiac, pulmonary, renal, liver, endocrine, central nervous system (CNS) diseases and cancers Previous history of gastric surgery Patients taking triple therapy for H. Pylori eradication History of taking proton pump inhibitor (PPI), histamine H2- receptor blocker (H2B) or antibiotic during previous two weeks Concomitant use of anticoagulant or corticosteroid Previous history of taking monoamine oxidase (MAO) inhibitors or tricyclic antidepressants (TCA) K30 B96.81 Functional dyspepsia Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: Esomeperazole Cap 40 mg BD + Amoxicillin Cap 500 mg 2*BD + Clarithromycin Tab 500 mg BD + Pyloshot Tab for 10 days Control group: Esomeperazole Cap 40 mg BD + Amoxicillin Cap 500 mg 2*BD + Clarithromycin Tab 500 mg BD for 10 days Helicobacter Pylori eradication rate. Timepoint: Six weeks after the end of therapy. Method of measurement: Stool Antigen Test. Rate of supplementation's side effects. Timepoint: After end of the therapy. Method of measurement: Patients' follow-up checklist. Patient's compliance rate. Timepoint: After end of the therapy. Method of measurement: Patients' follow-up checklist. Iran University of Medical Sciences Approved 2020-04-12 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, West Shahid Hemmat Highway, Intersection of Chamran and Sheikh Fazlollah Noori, Tehran Tehran Tehran Iran (Islamic Republic of)