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Comparison of Helicobacter pylori eradication treatment in children with chronic gastritis with non-eradication treatment of Helicobacter pylori in patients with chronic gastritis

Protocol summary

Study aim
Determining the comparative effect of Helicobacter pylori eradication treatment in children with chronic gastritis with no Helicobacter pylori eradication treatment in the recovery of patients with chronic gastritis.
Design
A single-blind, randomized,phase 2 clinical trial in 80 patients.The method of randomization will be a simple randomization, so that2 cards with the letters A and B are placed in front of the patient's parents and they choose one.Each letter belongs to one of2 groups.
Settings and conduct
In the present clinical trial, which is in the form of a blind, so that the patient will not know which group he belongs to. A total of 80 children aged 5-15 years old who referred to Hajer Shahrekord Hospital due to chronic abdominal pain and underwent endoscopy and were suffering from chronic gastritis. And of them, gastric biopsy was performed, and as a result of the biopsy, chronic inflammation of the stomach was reported, and Helicobacter pylori infection was reported in the histology, and at the same time, the patient's rapid urease test was positive, and they are included in the study.
Participants/Inclusion and exclusion criteria
Exclusion criteria: Consent of parents to participate in the study. Exclusion criteria: evidence of ulcers or any other pathology other than chronic gastritis in the stomach, esophagus or duodenum, functional abdominal pain, Malt's lymphoma, atrophic gastritis or hemi-sideroblastic anemia, suffering from ITP or hiatal hernia or a history of stomach cancer in first degree relatives.
Intervention groups
In group A, 40 children (helicobacter pylori and gastritis treatment will become chronic) . Group B, 40 children will receive only proton pump inhibitor (Someprazole) for 2 months
Main outcome variables
Frequency and severity of heartburn, reflux (GERD), localized poor abdominal pain, diffuse abdominal pain, epigastric abdominal pain, dyspepsia, vomiting.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230612058464N1
Registration date: 2023-07-24, 1402/05/02
Registration timing: retrospective

Last update: 2023-07-24, 1402/05/02
Update count: 0
Registration date
2023-07-24, 1402/05/02
Registrant information
Name
Ali agheel
Name of organization / entity
Olom pezeshki share kord
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
dr.agheel@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-14, 1402/03/24
Expected recruitment end date
2023-07-14, 1402/04/23
Actual recruitment start date
2023-06-14, 1402/03/24
Actual recruitment end date
2023-07-14, 1402/04/23
Trial completion date
2023-07-14, 1402/04/23
Scientific title
Comparison of Helicobacter pylori eradication treatment in children with chronic gastritis with non-eradication treatment of Helicobacter pylori in patients with chronic gastritis
Public title
Comparison of Helicobacter pylori eradication treatment in children with chronic gastritis with non-eradication treatment of Helicobacter pylori in patients with chronic gastritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parental consent to participate in the study Patients with no history of stomach cancer in children with Helicobacter pylori positive chronic gastritis, which is positive at the same time as the patient's RUT test, and the patient's history and clinical examination with the patient's endoscopic view and pathology report according to first degree relatives
Exclusion criteria:
Lack of parental consent to participate in the study Evidence of ulcers or any other pathology other than chronic gastritis in the stomach, esophagus and duodenum. Functional abdominal pain. Mallet's lymphoma. Hemi-sideroplastic anemia ITP Hiatal hernia Patients with history of stomach cancer in first-degree relatives
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization will be a simple randomization, so that 2 cards with the letters A and B are placed in front of the patient's parents and they choose one. Each letter belongs to one of 2 groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
According to the Helicobacter pylori treatment guidelines, both treatments are approved, and at the beginning of the study, the method of treatment will be explained to the parents of the participants, and only the parents will know about the type of treatment and the child will not know about the type of treatment, so the study is a single-blind study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahre-kord University of Medical Sciences
Street address
8, Fourth Ave., Shariati Blvd. Shahrekord city
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815844345
Approval date
2023-06-12, 1402/03/22
Ethics committee reference number
IR.SKUMS.MED.REC.1402.015

Health conditions studied

1

Description of health condition studied
Helicobacter positive chronic gastritis
ICD-10 code
R10.84
ICD-10 code description
Generalized abdominal pain

Primary outcomes

1

Description
Regurgitation frequency
Timepoint
before the study and after 2 months and after 4 months of treatment
Method of measurement
number

2

Description
Frequent heartburn
Timepoint
before the study and after 2 months and after 4 months of treatment
Method of measurement
number

3

Description
Vomiting frequency
Timepoint
before the study and after 2 months and after 4 months of treatment
Method of measurement
number

4

Description
Abdominal pain frequency localized poorly
Timepoint
before the study and after 2 months and after 4 months of treatment
Method of measurement
number

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A group of 20 children in such a way that the first 10 days of sequential therapy with S-Omeprazole 2 mg/kg/day in two divided doses and simultaneous Helicobacter pylori antibiotic treatment, first a 5-day course of amoxicillin 50 mg/kg/day in two divided doses And then on the second 5 days, they will receive clarithromycin 15 mg/kg/day in two divided doses and metronidazole 20 mg/kg/day in two divided doses, and then they will receive omeprazole 1 mg/kg/day in a single daily dose for 50 days. Helicobacter pylori antigen in stool is checked 4-8 weeks after the eradication treatment to ensure the treatment.
Category
Treatment - Drugs

2

Description
Intervention group: Group B, 20 children only proton pump inhibitor
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Dr. Hassan Talakesh
Street address
Shahrekord, Shariati Blvd., Imam Ali (A.S.) Specialized Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3224 2696
Email
info@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Elham Raiesi
Street address
Shahrekord, Kashani Blvd., University Headquarters, Building No. 2
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
vcrt@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Hassan Talakesh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord - Parastar St. - Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3222 0016
Email
talakesh.h@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Hassan Talakesh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord - Parastar St. - Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3222 0016
Email
talakesh.h@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Agheel
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Parastar street
City
Shahre-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815844345
Phone
+98 38 3222 0016
Fax
Email
dr.agheel@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is no further information
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
Refer to the scientific and experimental officer
What processes are involved for a request to access data/document
They should refer to the study center of Shahrekord University of Medical Sciences
Comments
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