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Comparative evaluation of triple therapy with high dose amoxicillin versus bismuth-based therapy in second-line therapy for eradication of helicobacter pylori infection in children

Protocol summary

Study aim
Comparative evaluation of triple therapy with high dose amoxicillin versus bismuth-based therapy in second-line therapy for eradication of helicobacter pylori infection in children
Design
In this study, patients referring to the gastroenterology clinic of Qods Hospital in Qazvin, aged 18-18 years, were studied by a project designer for one and a half years.   Patients will be randomly assigned to two A / B treatment groups . Patients are not aware of group allocation. The efficacy of triple-drug therapy with high-dose amoxicillin and bismuth-based therapy in the eradication of stage II Helicobacter pylori infection in children is compared.
Settings and conduct
The aim of this study was to evaluate the efficacy of triple-drug therapy with high dose amoxicillin and bismuth-based therapy in eradicating second stage Helicobacter pylori infection in children aged 18-18 years. To be.
Participants/Inclusion and exclusion criteria
Children with Helicobacter pylori infection who are known to be resistant to the first stage of eradication.Patients who have had a positive history of antibiotic, bismuth, proton pump inhibitors, histamine receptor 2 antagonist or non-steroidal anti-inflammatory drugs during the last 4 weeks.
Intervention groups
In group A, patients were treated with a high dose of omeprazole, metronidazole, amoxicillin, and folic acid over a 14-day period. In group B patients during a 14-day period treated with omeprazole, metronidazole Amoxicillin and bismuth subcitrate.
Main outcome variables
The percentage of patients with Helicobacter pylori antigen in their stool is negative.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191022045195N1
Registration date: 2020-01-08, 1398/10/18
Registration timing: registered_while_recruiting

Last update: 2020-01-08, 1398/10/18
Update count: 0
Registration date
2020-01-08, 1398/10/18
Registrant information
Name
Zahra Tohidlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3334 4157
Email address
ztohidlou@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2020-05-30, 1399/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of triple therapy with high dose amoxicillin versus bismuth-based therapy in second-line therapy for eradication of helicobacter pylori infection in children
Public title
Comparative evaluation of triple therapy with high dose amoxicillin versus bismuth-based therapy in second-line therapy for eradication of helicobacter pylori infection in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with Helicobacter pylori infection who are known to be resistant to the first stage of eradication
Exclusion criteria:
Patients who have had a positive history of taking drugs such as antibiotics during the last 4 weeks,  Bismuth, proton pump inhibitor, histamine receptor antagonist 2 or non-steroidal anti-inflammatory drug are excluded
Age
From 1 year old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
More than 1 sample in each individual
Number of samples in each individual: 1
In group A, patients were treated with a high dose of omeprazole, metronidazole, amoxicillin, and folic acid over a 14-day period.In group B patients during a 14-day period treated with omeprazole, metronidazoleAmoxicillin and bismuth subcitrate.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned based on a random number table (with the creation of binary blocks and then based on a random number table) after defining treatment regimens and explaining how they were administered and satisfaction of parents and children over the age of 7 years. A / B therapy will be assigned.
Blinding (investigator's opinion)
Single blinded
Blinding description
We have two therapies so we can build 6 quadruple blocks if we want to randomly block people. As follows: AABB, BBAA, ABAB, BABA, ABBA, BAAB We give each of these blocks a number from 1 to 6 and then randomly select these numbers from 1 to 6, for example if 3 randomly selected ABAB combinations are given, namely the first with treatment A, the second with treatment B, Nephersum is treated with treatment A and the fourth with treatment B.First we must first identify the blocks and number them each block inside an envelope that cannot be seen inside and then using a random number table based on the accident number A number that is the number one envelope is selected. Put the blocks in the envelope by someone who is not involved in the research.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin - Qods Children's Hospital
City
Qazvin
Province
Qazvin
Postal code
3415914595
Approval date
2019-11-06, 1398/08/15
Ethics committee reference number
IR.QUMS.REC.1398.180

Health conditions studied

1

Description of health condition studied
H.pylori Gastritis
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
The percentage of patients with Helicobacter pylori antigen in the stool sample is negative
Timepoint
Helicobacter pylori antigen assay is performed within 4 to 6 weeks after completion of treatment.
Method of measurement
Helicobacter pylori antigen in stool sample by ELISA

Secondary outcomes

1

Description
Percentage of people with side effects while taking the drug
Timepoint
From the beginning of the drug to the end of the study
Method of measurement
Self-expression of the patient, parents or carers

2

Description
Percentage of patients who were fully compliant with medication
Timepoint
Up to 4 weeks after starting the drug
Method of measurement
Self-expression of the patient, parents or carers

Intervention groups

1

Description
Intervention group 1: Patients will be treated with omeprazole, metronidazole, high-dose amoxicillin, and folic acid over a 14-day period. It should be noted that omeprazole is administered as a 1mg / kg capsule in two doses in the morning before breakfast and dinner for 28 days. In a dose of 75mg / kg suspension or capsule, it is administered in two divided doses for 14 days. Folic acid is administered to patients in this group at a dose of 1 mg once daily. The cause of placement of this fourth drug as placebo in this drug group is to prevent any possible bias in the placement of patients in any of the three or four drug groups. .Pharmaceutical Companies Name: Amoxicillin Suspension or Capsule (Manufactured by Farabi Company), Folic Acid as a Tablet (Manufactured by Enamel), Omoperazole as Capsule (Manufactured by Obidi Co.), Metronidazole as Syrup or Tablet (Manufactured by Alborz Drug Company) Bismuth Sub Citrate in tablet form (manufactured by Aria).
Category
Treatment - Drugs

2

Description
Intervention group: Intervention group 2: Patients will be treated with omeprazole, metronidazole, amoxicillin and bismuth subcitrate over a 14-day period. It should be noted that omeprazole is a 1mg / kg capsule in two doses before breakfast and dinner It is prescribed overnight for 28 days. Metronidazole 20 mg / kg syrup or tablet in two divided doses and Amoxicillin 50 mg / kg suspension or capsule in two divided doses and Substratum bismuth drug in 8 mg / kg doses in two divided doses Prescribed. Patients in each group will be monitored appropriately for possible drug use and any possible side effects of the medications used. Patients in each group will be without medication for at least 4 weeks after completion of treatment. Helicobacter pylori antigen screening is performed within 4 to 6 weeks after completion of treatment. If the test results are negative, the effect of helicobacter pylori eradication therapy is considered successful in the second phase of treatment.In the next step, the study data will be analyzed after collecting and completing the relevant checklist and then the results will be compared in each group.It should be noted that in any case of a candidate for Helicobacter pylori eradication treatment, he or she will need treatment, whether it is part of a research project or not.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Qods Children's Hospital
Full name of responsible person
Zahra Tohidlou
Street address
Qazvin Shahid Beheshti Boulevard, beginning of East Palestine, Qods Square, Quds Medical Center
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3334 8070
Fax
+98 28 3344 0880
Email
hosghods@qums.ac.ir
Web page address
http://qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mahdi ٍEmamjome
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
4595134159
Phone
+98 28 3333 4807
Fax
Email
Cgd_rc@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Rita Bagherian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Beheshti Boulevard, east of Palestine, Quds Square
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
r.bagherian@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Rita Bagherian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Beheshti Boulevard, east of Palestine, Quds Square, Quds Hospital
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
r.bagherian@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Tohidlou
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Shahid Beheshti Boulevard, east of Palestine, Quds Square, Quds Hospital
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
ztohidlou@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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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