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| Name | Class |
|---|---|
| Ministry of Health and Welfare, Taiwan | OTHER_GOV |
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The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel 10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levofloxacin-based concomitant | Experimental | Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day10 Metronidazole 500 mg BID day1~day10 Levofloxacin 500 mg QD day1~day10 |
|
| Sequential | Active Comparator | Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day5 Metronidazole 500 mg BID day6~day10 Clarithromycin 500 mg BID day6~day10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | H. pylori eradication therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication rate | C13-UBT to confirm the H. pylori eradication | 1-4 months after eradication therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Acute inflammatory score | Gastric tissue obtained from antrum (2 pieces), body (2 pieces) and cardia (1 piece) were scoring by modified Sydney system and specific staining. Acute inflammatory score (AIS) can be assessed by the sum of these five pathologic tissues | 1-4 weeks after gastric tissue obtained by upper endoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yao-Jong Yang, PhD | National Cheng-Kung University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29082856 | Derived | Yang YJ, Wu CT, Ou HY, Lin CH, Cheng HC, Chang WL, Chen WY, Yang HB, Lu CC, Sheu BS. Male non-insulin users with type 2 diabetes mellitus are predisposed to gastric corpus-predominant inflammation after H. pylori infection. J Biomed Sci. 2017 Oct 30;24(1):82. doi: 10.1186/s12929-017-0389-x. | |
| 28266875 | Derived |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| D000658 | Amoxicillin |
| D008795 | Metronidazole |
| D064704 | Levofloxacin |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Amoxicillin | Drug | H. pylori eradication therapy |
|
| Metronidazole | Drug | H. pylori eradication therapy |
|
|
| Levofloxacin | Drug | H. pylori eradication therapy |
|
|
| Clarithromycin | Drug | H. pylori eradication therapy |
|
|
| Chronic inflammatory score |
Chronic inflammatory score (CIS) can be assessed by the sum of these five pathologic tissues |
| 1-4 weeks after gastric tissue obtained by upper endoscopy |
| H. pylori density score | H. pylori density score (HPDS) can be assessed by the sum of these five pathologic tissues | 1-4 weeks after gastric tissue obtained by upper endoscopy |
| Intestinal metaplasia | Presence of intestinal metaplasia can be evaluated from these five pathologic tissues | 1-4 weeks after gastric tissue obtained by upper endoscopy |
| Spasmolytic polypeptide expressing metaplasia | Presence of spasmolytic polypeptide expressing metaplasia can be evaluated from these five pathologic tissues by special TFF-2 stains | 1-4 weeks after gastric tissue obtained by upper endoscopy |
| H. pylori resistance panel | E-test evaluation for antibiotic (amoxicillin, metronidazole, clarithromycin, tetracycline and levofloxacin) resistance | 1-4 weeks after H. pylori culture obtained by upper endoscopy |
| Yang YJ, Wu CT, Ou HY, Lin CH, Cheng HC, Chang WL, Chen WY, Yang HB, Lu CC, Sheu BS. Ten days of levofloxacin-containing concomitant therapy can achieve effective Helicobacter pylori eradication in patients with type 2 diabetes. Ann Med. 2017 Sep;49(6):479-486. doi: 10.1080/07853890.2017.1294761. Epub 2017 Mar 7. |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |