The effect of bismuth supplementation on the eradication of Helicobacter pylori in sequential therapy
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 124 patients. The website www.sealedenvelope.com/simple-randomiser/v1/lists was used for randomization.
Settings and conduct
In this study, patients referred to the gastroenterology clinic of Shahid Beheshti Hospital, Kashan with symptoms of dyspepsia and a definitive diagnosis of Helicobacter pylori infection were examined. Then, they were randomly assigned to two control groups (standard treatment) and intervention (standard treatment + bismuth) and after the treatment period, stool antigen testing was performed to confirm the eradication of H. pylori infection.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Patients with functional dyspepsia or gastroduodenal ulcer with indication for eradication of Helicobacter pylori infection
- Confirmation of Helicobacter pylori infection by endoscopy pathology result or positive result of Helicobacter pylori stool antigen
- Age at least 18 years
Non-Inclusion criteria:
- Previous eradication of Helicobacter pylori
- Use of antibiotics, PPIs or chemotherapy drugs within 4 weeks prior to the study
- History of gastrectomy or complicated peptic ulcer
- Pregnant and lactating women
- Patients with uncompensated renal and heart failure
Intervention groups
Control group: Standard treatment including omeprazole (20 mg every 12 hours) + amoxicillin 500 mg (1000 mg every 12 hours) in the first half of the treatment and omeprazole (20 mg every 12 hours) along with clarithromycin (500 mg every 12 hours) and tinidazole (500 mg twice a day) for two weeks. Intervention group: Standard treatment + bismuth subcitrate 120 mg every 12 hours, 2 tablets for 14 days.
Main outcome variables
Eradication of Helicobacter pylori
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250529065965N1
Registration date:2025-08-10, 1404/05/19
Registration timing:retrospective
Last update:2025-08-10, 1404/05/19
Update count:0
Registration date
2025-08-10, 1404/05/19
Registrant information
Name
Fatemeh Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5510 9999
Email address
sadeghi.98.1f@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
2024-04-08, 1403/01/20
Actual recruitment end date
2024-07-22, 1403/05/01
Trial completion date
2024-10-22, 1403/08/01
Scientific title
The Efficacy of standard Sequential therapy with Bismuth in Helicobacter pylori Eradication
Public title
The Efficacy of Bismuth in Helicobacter pylori Eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with functional dyspepsia or gastroduodenal ulcer who have an indication for eradicating Helicobacter pylori infection
Confirmation of Helicobacter pylori infection through pathology results obtained from endoscopy or positive stool antigen test for Helicobacter pylori
Minimum age 18 years
Exclusion criteria:
Previous eradication of Helicobacter pylori
Use of antibiotics, PPIs, or chemotherapeutic agents within the 4 weeks prior to the study
Patients with a history of gastrectomy or complicated peptic ulcer
Pregnant and nursing women
established.Patients with recompensated kidney and heart failure
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
124
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
First, the intervention group was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists randomization list was prepared by selecting a sample size of 124 (two groups of 62) and permuted block randomization method (block size=4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups A or B. For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B and the same will continue until the last sample (124th person).
Blinding (investigator's opinion)
Single blinded
Blinding description
The laboratory (Infection Eradication Evaluator) will be blinded to the study group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Working Group/Committee, Faculty of Medicine and Dentistry, Kashan University of Med
Street address
Ethics Committee, Vice-Chancellor for Research and Technology, Kashan University of Medical Sciences, Qotb-e Ravandi Boulevard, Kashan, Isfahan Province, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2023-10-01, 1402/07/09
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.154
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori]
Primary outcomes
1
Description
Eradication of Helicobacter pylori infection
Timepoint
After the end of the antibiotic treatment period, omeprazole treatment was continued for 4 weeks, and eradication of the infection was measured two weeks after omeprazole was discontinued.
Method of measurement
Fecal antigen test
Secondary outcomes
1
Description
Side effects of treatment (bitter taste in the mouth, black stool, diarrhea, nausea, vomiting)
Timepoint
After the treatment period
Method of measurement
Patient self-expression
Intervention groups
1
Description
Intervention group: Standard treatment (omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours), amoxicillin capsules 500 ml produced by Al-Hawi Pharmaceutical Company (1000 mg every 12 hours) in the first half of the treatment and omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours) along with clarithromycin tablets produced by Tehran Shimi Company (500 mg every 12 hours) and tinidazole produced by Pars Darou Company (500 mg twice a day) for two weeks) + bismuth subcitrate 120 mg produced by Iran Darou Company, which is given to patients 2 tablets every 12 hours for 14 days
Category
Treatment - Drugs
2
Description
Control group: Standard treatment includes omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours), amoxicillin capsules 500 ml produced by Al-Hawi Pharmaceutical Company (1000 mg every 12 hours) in the first half of the treatment and omeprazole capsules produced by Iran Darou Company (20 mg every 12 hours) along with clarithromycin tablets produced by Tehran Shimi Company (500 mg every 12 hours) and tinidazole produced by Pars Darou Company (500 mg twice a day) for two weeks.