Comparison of the effectiveness of triple and quadruple therapy regimens for Helicobacter pylori eradication in patients with positive stool exam: A randomized, single-blind clinical trial study
Determining and comparing the effectiveness of two triple and quadruple treatment regimens for Helicobacter pylori eradication in patients referred to Imam Ali Clinic, Shahrekord
Design
A phase 3, single-blind, randomized, controlled clinical trial on 126 patients with Helicobacter pylori who were randomly assigned to two groups A and B. 126 cards, 63 of which had the letter A written on them and the other 63 had the letter B written on them, were placed in an envelope in a jumbled manner, and one card was randomly drawn for each patient. The letter appearing on the card indicated the patient's treatment group.
Settings and conduct
This clinical trial study will be conducted on 126 patients with Helicobacter pylori in Imam Ali clinic of Shahrekord. Patients will be randomly assigned to two groups A and B and will undergo 14-day treatment with eradication regimens. primary outcome: the eradication rate of Helicobacter pylori as defined by a negative stool antigen test. Secondary outcomes: adherence to treatment, clinical symptoms of patients, the rate of side effects during treatment. This study is single-blinded, meaning that the intervention is performed by another person and the researcher is unaware of the type of grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Helicobacter pylori positive
First attempt to eradicate Helicobacter pylori
Age over 18 years
No previous Helicobacter treatment
Exclusion criteria:
Pregnancy
Antibiotic consumption
Negative stool antigen test 4 weeks after the end of treatment
Side effect
Symptoms of the disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250227064868N1
Registration date:2025-05-02, 1404/02/12
Registration timing:registered_while_recruiting
Last update:2025-05-02, 1404/02/12
Update count:0
Registration date
2025-05-02, 1404/02/12
Registrant information
Name
Ali Sanei Dehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 8693
Email address
sanei@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-05, 1404/01/16
Expected recruitment end date
2025-06-06, 1404/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of triple and quadruple therapy regimens for Helicobacter pylori eradication in patients with positive stool exam: A randomized, single-blind clinical trial study
Public title
Comparison of the effectiveness of triple and quadruple therapy regimens for Helicobacter pylori eradication in patients with positive stool antigen test
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Helicobacter pylori positive
Patients with first attempt at Helicobacter pylori eradication
Age over 18 years
Exclusion criteria:
previous treatment for Helicobacter pylori eradication
pregnancy or breastfeeding
previous treatment for eradication of Helicobacter pylori
malignant neoplasms
history of gastrectomy
history of allergy or adverse reactions to the study drugs
history of use of PPIs and Potassium-Competitive Acid Blockers in the 2 weeks prior to randomization
hematological disease, central nervous system infection, infectious mononucleosis, glucose-galactose malabsorption, lactase deficiency, galactose intolerance, or torsades de pointes
Concomitant use of drugs that may interact with the drugs in the present study
Withdrawal of consent or failure to complete the final test follow-up
Development of drug hypersensitivity or intolerable adverse effects
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
In this way, 126 cards, 63 of which have the letter A written on them and the other 63 have the letter B written on them, are placed in a jumbled envelope, and one card is drawn at random for each patient. The letter that appears on the card indicates the patient's treatment group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, due to the impossibility of drug matching, blinding is not performed for participants. However, blinding is performed for healthcare personnel (physicians), data collectors, and outcome assessors, and to a lesser extent, the Data Safety and Monitoring Board and those preparing the manuscript.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord Univercity of Medical Sciences
Street address
Kashani Blvd
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2024-07-31, 1403/05/10
Ethics committee reference number
IR.SKUMS.MED.REC.1403.056
Health conditions studied
1
Description of health condition studied
H.pilory infection
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
The eradication rate of Helicobacter pylori, which is defined as a negative stool antigen test.
Timepoint
The stool antigen test is performed at the beginning of the study (before the intervention as an inclusion criterion) and four weeks after the completion of treatment.
Method of measurement
Stool Antigen Test
Secondary outcomes
1
Description
Adherence to treatment
Timepoint
Four weeks after the completion of treatment
Method of measurement
Direct questioning of the patient and writing on the checklist
2
Description
The clinical symptoms of patients (pain, bloating, appetite, heartburn) and the incidence of side effects during treatment as reported by the patients.
Timepoint
After the completion of treatment
Method of measurement
Direct questioning of the patient and writing on the checklist