Evaluation of the impact of probiotic supplementation on the efficacy of therapy in eradicating Helicobacter pylori
Design
This is a double-blind, randomized clinical trial with a parallel design and a control group. This randomized study, phases 2-3, will be conducted on 120 patients with Helicobacter pylori. A random block design is used for randomization, and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at Imam Reza Hospital of Kermanshah, is double-blinded. The patients are aware of participating in the study and receiving the new drug, but the researcher and the participant will be kept blind to which group will receive the new drug and which group will receive the placebo. The beginning of the study, benefits, and side effects. The possibility of probiotic treatment is explained to patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Dyspepsia symptoms for at least six months or more
Exclusion criteria: History of kidney failure; Patients with a history of taking any antibiotics during the last month and a history of taking proton pump inhibitors and antacids in the last week; Consumption of alcohol or drugs or non-steroidal anti-inflammatory drugs
Intervention groups
The intervention group was given a standard four-drug regimen against Helicobacter (one gram of amoxicillin, 250 mg of metronidazole, 300 mg of bismuth, and 40 mg of pantoprazole) for ten days along with two probiotic tablets daily every twelve hours for Four weeks follow.
The placebo group also received the regimen of four standard anti-helicobacter drugs (Same as the intervention group) for ten days and placebo capsules two tablets daily every twelve hours for Four weeks follow.
Main outcome variables
Helicobacter pylori infection rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N191
Registration date:2022-12-21, 1401/09/30
Registration timing:prospective
Last update:2022-12-21, 1401/09/30
Update count:0
Registration date
2022-12-21, 1401/09/30
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the impact of probiotic supplementation on the efficacy of therapy in eradicating Helicobacter pylori
Public title
The effect of probiotic supplementation on the effectiveness of stomach infection treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
dyspepsia symptoms for at least 6 months or more
Exclusion criteria:
History of kidney failure
Patients with a history of taking any antibiotics during the last month and a history of taking proton pump inhibitors and antacids in the last week.
Patients with stomach tumors
Consumption of alcohol or drugs or non-steroidal anti-inflammatory drugs
Having an endoscopic pattern of gastritis
Family history of gastrointestinal disease and anti-Helicobacter pylori treatment regimen
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Using 12 random blocks that will be created using the website https://www.sealedenvelope.com, the samples are studied in each of the groups. The researcher responsible for collecting information is unaware of the type of allocation of samples to the study groups. Coding is done by one of the collaborators of the project. So that a) 12 blocks are considered. b) An English letter is assigned to each of the groups: A to the intervention group, B to the placebo group c) A sequence will be created for a sample size of 120. d) For the random allocation concealment process, ten opaque envelopes (10 constructed blocks) and 120 cards (the size of the total sample) will be made. Inside each envelope, 12 cards will be placed in the sequence in each block. Block numbers were written on each envelope. The name of the desired group will be written on each card in sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind; in this way, the participant is not aware of his allocation to the probiotic treatment group or the placebo group; in addition, the researcher is unaware of the members of the two groups. Each dose of medicine is individually packaged and has an identification number. Vials and boxes of medicine and placebo are supplied in completely similar appearance and packaging, which will cause blinding of the participants and the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2022-09-18, 1401/06/27
Ethics committee reference number
IR.KUMS.MED.REC.1401.122
Health conditions studied
1
Description of health condition studied
Helicobacter pylori Infection
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Helicobacter pylori infection rate
Timepoint
At the beginning of the study and six weeks after the start of the study
Method of measurement
Using the lateral flow technique
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group was given a standard four-drug regimen against Helicobacter (one gram of amoxicillin, 250 mg of metronidazole, 300 mg of bismuth, and 40 mg of pantoprazole) for ten days along with two probiotic tablets (Rist Fermentation Company) daily every twelve hours for Four weeks follow.
Category
Treatment - Drugs
2
Description
The placebo group also received the regimen of four standard anti-helicobacter drugs (One gram of amoxicillin, 250 mg of metronidazole, 300 mg of bismuth, and 40 mg of pantoprazole) for ten days and placebo capsules (Rist Fermentation Company) two tablets daily every twelve hours for Four weeks follow.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Eideh Ramezani Ghanbari
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
eidehghambari63@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Eideh Ramezan Ghanbari
Position
Internal resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
eidehghambari63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Homayoon Bashiri
Position
Member of the academic staff of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Digestion
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
hbashirimd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Eideh Ramezani Ghanbari
Position
Internal resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
eidehghambari63@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD