A comparison between standard triple therapy plus Lactobacillus reuteri supplementation versus standard triple therapy on H.pylori eradication among patients with dyspepsia
Design
This phase 2-3 randomized clinical trial will be done on 80 patients with dyspepsia .The patients will be randomly assigned into treatment groups using a computer-generated randomization table
Settings and conduct
Patients with dyspepsia will be randomly assigned into the intervention group and control group to receive treatment regimens for 10 days. Patients will be examined at the end of treatment to assess compliance rates and side effects of regimens and six weeks after that to assess H. Pylori eradication using stool antigen test. Data will be recorded on a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged between 18 to 70 years old with dyspepsia; H. Pylori documentation by antral biopsy (Rapid Urease Test or Giemsa staining) or Urea Breath Test; Exclusion criteria: Pregnancy or breast- feeding; Significant underlying diseases such as cardiac, pulmonary, renal, liver, endocrine, central nervous system (CNS) diseases and cancers; previous history of gastric surgery; History of taking triple therapy for H. Pylori eradication, proton pump inhibitor (PPI), histamine H2- receptor blocker (H2B) or antibiotic during previous two weeks, concomitant use of anticoagulant or corticosteroid
Intervention groups
Intervention group: Esomeperazole 40 mg BD + Amoxicillin 1000 mg BD + Clarithromycin 500 mg BD + Pyloshot BD,orally for 10 days
Control group: Esomeperazole 40 mg BD + Amoxicillin 1000 mg BD + Clarithromycin 500 mg BD, orally for 10 days
Main outcome variables
H. Pylori eradication rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141201020178N10
Registration date:2020-09-11, 1399/06/21
Registration timing:registered_while_recruiting
Last update:2020-09-11, 1399/06/21
Update count:0
Registration date
2020-09-11, 1399/06/21
Registrant information
Name
Marjan Mokhtare
Name of organization / entity
Iran University of Medical sciences,Rasoul Akram Hospital,Colorectal Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 2845
Email address
mokhtare.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-16, 1399/02/27
Expected recruitment end date
2020-10-17, 1399/07/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Lactobacillus reuteri Supplementation versus Standard Triple Therapy for Helicobacter pylori Eradication among Patients with Dyspepsia
Public title
Lactobacillus reuteri Supplementation for Helicobacter pylori Eradication among Patients with Dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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)
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, West Shahid Hemmat Highway, Intersection of Chamran and Sheikh Fazlollah Noori, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-04-12, 1399/01/24
Ethics committee reference number
IR.IUMS.FMD.REC.1399.031
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
2
Description of health condition studied
Helicobacter pylori
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Helicobacter Pylori eradication rate
Timepoint
Six weeks after the end of therapy
Method of measurement
Stool Antigen Test
Secondary outcomes
1
Description
Rate of supplementation's side effects
Timepoint
After end of the therapy
Method of measurement
Patients' follow-up checklist
2
Description
Patient's compliance rate
Timepoint
After end of the therapy
Method of measurement
Patients' follow-up checklist
Intervention groups
1
Description
Intervention group: Esomeperazole Cap 40 mg BD + Amoxicillin Cap 500 mg 2*BD + Clarithromycin Tab 500 mg BD + Pyloshot Tab for 10 days
Category
Treatment - Drugs
2
Description
Control group: Esomeperazole Cap 40 mg BD + Amoxicillin Cap 500 mg 2*BD + Clarithromycin Tab 500 mg BD for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul-e Akram hospital
Full name of responsible person
Dr. Marjan Mokhtare
Street address
Rasul-e Akram Hospital, Niayesh St., Sattarkhan Ave., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6735 2477
Email
mokhtare.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Marjan Mokhtare
Street address
Iran University of Medical Sciences, West Shahid Hemmat Highway, Intersection of Chamran and Sheikh Fazlollah Noori, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1000
Email
mokhtare.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marjan Mokhtare
Position
Associate professor of Gastroenterology and Hepatology
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology and Hepatology
Street address
Rasul-e Akram Hospital, Niayesh St., Sattarkhan Ave., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6735 2477
Email
mokhtare.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasul-e Akram Hospital
Full name of responsible person
Marjan Mokhtare
Position
Associate Professor of Gastroenterology and Hepatology
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology and Hepatology
Street address
Rasul-e Akram Hospital, Niayesh St., Sattarkhan Ave., Tehran