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Evaluating the Effectiveness of Treatment by piloshot Probiotic and Standard Quadruple Regimen in Patients with Helicobacter Pylori

Protocol summary

Study aim
Evaluating the Effectiveness of Treatment by piloshot Probiotic and Standard Quadruple Regimen in Patients with Helicobacter Pylori
Design
The present study will be performed as a randomized clinical trial on patients with symptomatic HP infection.Patients enter the study after obtaining informed consent and will be randomly divided into two groups of 100 intervention and control who will be matched in terms of demographic conditions.None of the patients can choose between placebo or probiotic and the conditions will be the same for both groups.
Settings and conduct
HP infection can be confirmed by examining tissue samples from endoscopy and urease test.The duration of treatment will be 14 days.Patients will not take any medication for up to a month after treatment and will be followed up for HP eradication.Stool antigen test is used to follow patients in a fixed laboratory
Participants/Inclusion and exclusion criteria
Inclusion criteria:Infection with HP based on urease test on endoscopic tissue samples,Age over 18 years,Indications for HP eradication treatment,Satisfaction to enter the project and perform endoscopy.Exclusion criteria:Dissatisfaction with participating in the project,Dissatisfaction or possibility of endoscopy,No endoscopic indication,History of treatment failure,History of drug allergy or contraindication to amoxicillin, clarithromycin and bismuth,Take another herbal medicine or probiotic at the same time
Intervention groups
The intervention group will be treated with a four-drug regimen including amoxicillin,clarithromycin,bismuth,pantoprazole with 2 piloshot probiotic capsules daily and the control group will be treated with the above-mentioned four drug regimen with 2 piloshot placebo capsules daily
Main outcome variables
Eradicate Helicobacter pylori infection,drug side effects,clinical symptoms after treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210719051943N2
Registration date: 2022-03-06, 1400/12/15
Registration timing: prospective

Last update: 2022-03-06, 1400/12/15
Update count: 0
Registration date
2022-03-06, 1400/12/15
Registrant information
Name
mehdi pezeshki modares
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2000
Email address
mpezeshkim@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effectiveness of Treatment by piloshot Probiotic and Standard Quadruple Regimen in Patients with Helicobacter Pylori
Public title
Eradicate Helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infection with Helicobacter pylori based on urease test results on endoscopic tissue samples Age over 18 years Indications for Helicobacter pylori eradication treatment Satisfaction to enter the project and perform endoscopy
Exclusion criteria:
Dissatisfaction with participating in the project Dissatisfaction or possibility of endoscopy No endoscopic indication History of treatment failure History of drug allergy or contraindication to amoxicillin, clarithromycin and bismuth Take another herbal medicine or probiotic at the same time
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method will be used and the block size is 4. Considering our sample size equal 200, we used 50 blocks. The selection among 6 possible blocks will be conducted based on simple random sampling. 6 possible blocks are including AABB, ABAB, BBAA, BABA, ABBA, BAAB
Blinding (investigator's opinion)
Double blinded
Blinding description
After completing the entry criteria and obtaining informed consent, patients are referred to a caregiver to receive medication.At this stage, the caregiver accidentally gives the patient drug packages that include groups A and B.The patient, the researcher, and the caregiver have no say in the selection.After completing the treatment process by patients and follow-up to eradicate, the examination begins as to which patient has taken which drug.Thus, none of the groups of researchers, participants and caregivers are involved in the choice of treatment
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Qom University of Medical Sciences
Street address
Beheshti Blvd. Shahid Beheshti Hospital
City
Qom
Province
Ghoum
Postal code
3719964797
Approval date
2022-01-02, 1400/10/12
Ethics committee reference number
IR.MUQ.REC.1400.202

Health conditions studied

1

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
Eradicate Helicobacter pylori infection
Timepoint
Patients in the intervention group underwent a four-drug regimen for Helicobacter pylori eradication, including amoxicillin capsules plus clarithromycin capsules and bismuth tablets plus pantoprazole, plus 2 capsules piloshot daily,and patients in the control group will be treated with the above four-drug regimen along with 2 placebo tablets of Pilochat drug daily. The duration of the treatment period will be 14 days. Helicobacter pylori will be followed up after treatment
Method of measurement
Bacterial fecal antigen test

2

Description
Drug side effects
Timepoint
Patients in the intervention group underwent a four-drug regimen for Helicobacter pylori eradication, including amoxicillin capsules plus clarithromycin capsules and bismuth tablets plus pantoprazole, plus 2 capsules piloshot daily,and patients in the control group will be treated with the above four-drug regimen along with 2 placebo tablets of Pilochat drug daily. The duration of the treatment period will be 14 days. Helicobacter pylori will be followed up after treatment
Method of measurement
questionnaire

3

Description
Clinical symptoms after treatment
Timepoint
Patients in the intervention group underwent a four-drug regimen for Helicobacter pylori eradication, including amoxicillin capsules plus clarithromycin capsules and bismuth tablets plus pantoprazole, plus 2 capsules piloshot daily,and patients in the control group will be treated with the above four-drug regimen along with 2 placebo tablets of Pilochat drug daily. The duration of the treatment period will be 14 days. Helicobacter pylori will be followed up after treatment
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Patients in the control group will be treated with the four-drug regimen of two capsules of amoxicillin 500 every 12 hours,one clarithromycin 500 capsules every 12 hours,one pantoprazole 40 every 12 hours,two bismuth tablets every 12 hours with 2 placebo of piloshot daily(contains lactose mesh 200,ac-di-sol,talc,colloidal silicon dioxide and magnesium stearate)
Category
Treatment - Drugs

2

Description
Intervention group: :Patients in the intervention group under the helicobacter pylori eradication will be treated with four-drug regimen, including two capsules of amoxicillin 500 every 12 hours plus one clarithromycin 500 capsules every 12 hours and two bismuth tablets every 12 hours plus one pantoprazole 40 every 12 hours will be accompanied by 2 capsules of Pilochet (containing Lactobacillus ruteri, casei ,Acidophilus and Bifidobacterium) daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mehdi Pezeshki Modares
Street address
Beheshti Blvd. Shahid Beheshti Hospital
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2526
Email
mpezeshkim@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Street address
Safashar
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3285 4011
Email
Ehsansharifipour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Mahdi Pezeshki Modares
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Beheshti Blvd. Shahid Beheshti Hospital
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2526
Email
mpezeshkim@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mehdi Pezeshki Modares
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Beheshti Blvd. Shahid Beheshti Hospital
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
mpezeshkim@muq.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mehdi Pezeshki Modares
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Beheshti Blvd. Shahid Beheshti Hospital
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
mpezeshkim@muq.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
According to the rules of the COPE
From where data/document is obtainable
mpezeshkim@gmail.com
What processes are involved for a request to access data/document
By email the responsible author(mpezeshkim@gmail.com)
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