Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance.
Patients who were confirmed to be positive for Helicobacter Pylori infection were randomly assigned to the eradication treatments. At four weeks after completion of eradication therapy, H. pylori tests were performed with a Stool antigen test.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levofloxacin-based sequential Therapy | Active Comparator |
1. Tablet Levofloxacin 500 mg BID for five days 2. Tablet Tinidazole 500mg BID for five days 3. Capsule Omeprazole 20 mg BID for five days Infection eradication will be observed and confirmed by stool antigen test correlated with the signs and symptoms |
|
| Moxifloxacin-based Triple Therapy | Active Comparator |
Infection eradication will be observed and confirmed with a stool antigen test along with patient compliance and tolerability observance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID | Drug | The eradication rate of H. Pylori with levofloxacin-based sequential therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori status one month after treatment. | Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy. | One month after finishing with therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection. | Compliance will be measured by counting pills that were taken during therapy. More than or equal 80 % of taken pills will be consider as good compliance | One month after finishing with therapy. |
| Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Iyad N Muhammad, Ph.D. | Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jamal Noor Hospital, Karachi | Karachi | Sindh | 74800 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25547786 | Background | Rakici H, Ayaz T, Akdogan RA, Bedir R. Comparison of levofloxacin- and moxifloxacin-based triple therapies with standard treatment in eradication of Helicobacter pylori as first-line therapy. Digestion. 2014;90(4):261-4. doi: 10.1159/000369788. Epub 2014 Dec 24. | |
| 32351290 | Background | Mori H, Suzuki H. Update on quinolone-containing rescue therapies for Helicobacter pylori infection. World J Gastroenterol. 2020 Apr 21;26(15):1733-1744. doi: 10.3748/wjg.v26.i15.1733. |
Not provided
Not provided
IPD will be shared and made available for other researchers after due coding. The data will be summarized and tabulated in the thesis and article manuscripts. The IPD would include the basic information and demographic data, the treatment protocols, informed consent, and the outcome measures data.
The data will be shared and made permanently available on the formats mentioned above by January 2024.
The data will be shared by the researches in RCT, working on H. pylori therapy or diagnosis. Communication would be electronically made through emails.
Not provided
Not provided
Patients were randomized into two regimens:
Not provided
Not provided
Not provided
Not provided
|
| Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID | Drug | The eradication rate of H. Pylori with moxifloxacin-based triple therapy |
|
|
Patients will be asked to report any adverse effect that occurred during treatment. They will be divided into groups according to the degree of limiting daily activities: no adverse effects; mild (no limit of activities); moderate (partially limited activities); severe (completely limited activities). |
| One month after finishing with therapy. |
| 34390083 | Background | Hsu PI, Tsay FW, Kao JY, Peng NJ, Chen YH, Tang SY, Kuo CH, Kao SS, Wang HM, Wu IT, Shie CB, Chuah SK, Wu DC; Taiwan Acid-related Disease, Microbiota (TARD-M) Consortium. Tetracycline-levofloxacin versus amoxicillin-levofloxacin quadruple therapies in the second-line treatment of Helicobacter pylori infection. Helicobacter. 2021 Oct;26(5):e12840. doi: 10.1111/hel.12840. Epub 2021 Aug 12. |
| 26401089 | Background | Hwang JJ, Lee DH, Yoon H, Shin CM, Park YS, Kim N. Efficacy of moxifloxacin-based sequential and hybrid therapy for first-line Helicobacter pylori eradication. World J Gastroenterol. 2015 Sep 21;21(35):10234-41. doi: 10.3748/wjg.v21.i35.10234. |
| ID | Term |
|---|---|
| C494814 | BID protein, human |
| D009853 | Omeprazole |
| D014011 | Tinidazole |
| D064704 | Levofloxacin |
| D000658 | Amoxicillin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
Not provided
Not provided