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| Sponsors and Collaborators: |
Hamamatsu University Oita University |
| Information provided by: | Hamamatsu University |
| ClinicalTrials.gov Identifier: | NCT00281047 |
Purpose
FP-10 is a food ingredient derived from milk casein. FP-10 can inhibit H. pylori to attach to the gastric epithelium. FP-10 has been made clear to decrease the intragastric urease activity (which is assumed to be produced by H. pylori) measured by the urea breath test. FP-10 can also detach H. pylori from gastric epithelium. We have hypothesized that FP-10 increases the eradication rates by a triple therapy with a proton pump inhibitor, amoxicillin, and clarithromycin.
| Condition | Intervention | Phase |
|
Helicobacter Pylori |
Drug: FP-10 |
Phase II Phase III |
| ChemIDplus related topics: | Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Clarithromycin Lansoprazole Casein |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | The Phase 2 Study of FP-10, the Food Ingredient Derived From Milk Casein, on the Eradication Rates of Helicobacter Pylori by a Triple Therapy With Lansoprazole, Amoxicillin, and Clarithromycin |
| Estimated Enrollment: | 138 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | May 2006 |
H. pylori -positive patients older than 15 years of age with gastritis, gastric ulcer, duodenal ulcer, or gastroduodenal ulcer are invited to participate in the study. These patients had endoscopically and histologically proven ulcers or active chronic gastritis and are all H. pylori-positive. Written informed consent to participation must be obtained from each patient before the study.
During gastroduodenoscopy, biopsy specimens obtained from both the antrum and the corpus of the greater curvature are subjected to the bacterial susceptibility to clarithromycin by culture test or measurements of 23S rRNA mutations at positions 2142 and 2143 (from adenine to guanine).
Patients are treated with 30 mg of lansoprazole bid, 200 mg of clarithromycin bid, and 750 mg of amoxicillin bid for one week. In addition, they take placebo bid, FP10 1 g bid, or FP-10 2 g bid (2 hour after breakfast and at the bed time) for the same one week. Administration of placebo, FP-10 1 g or FP-10 2 g are performed in a double blinded manner.
Eradication of H. pylori was confirmed by a 13C-urea breath test performed one month after eradication therapy. Throughout the study period, the investigators involved in the assessment of H. pylori eradication are blinded to susceptibility to clarithromycin H. pylori strains.
Eligibility
| Ages Eligible for Study: | 15 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
H. pylori-positive patients who have never undergo the H. pylori eradication therapy -
Exclusion Criteria:
Patients not infected with H. pylori, Patients who are allergic to amoxicillin, clarithromycin, lansoprazole, 13C-urea, or milk casein
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Contacts and Locations| Contact: Takahisa Furuta, MD, PhD | 81-53-435-2850 | furuta@hama-med.ac.jp |
| Contact: Kazunari Murakami, MD, PhD | 81-97-586-6193 | murakam@med.oita-u.ac.jp |
| Japan | |||||
| University Hospital of Oita University Faculty of Medicine | Recruiting | ||||
| Oita, Japan, 879-5593 | |||||
| Contact: Kazunari Murakami, MD, PhD 81-97-586-6193 murakam@med.oita-u.ac.jp | |||||
| Principal Investigator: Kazunari Murakami, MD, PhD | |||||
| Japan, Oita | |||||
| Oita Kouseiren Tsurumi Hospital | Recruiting | ||||
| Beppu, Oita, Japan, 874-8585 | |||||
| Contact: Takayuki Nagai, MD. PhD 81-977-23-7111 ikyoku@ok-tsurumi.com | |||||
| Principal Investigator: Takayuki Nagai, MD, PhD | |||||
| Japan, Shizuoka | |||||
| University Hospital of Hamamatsu University School of Medicine | Recruiting | ||||
| Hamamatsu, Shizuoka, Japan, 431-3192 | |||||
| Contact: Takahisa Furuta, MD, PhD 81-53-435-2850 furuta@hama-med.ac.jp | |||||
| Principal Investigator: Takahisa Furuta, MD, PhD | |||||
| Sub-Investigator: Naohito Shirai, MD, PhD | |||||
| Sub-Investigator: Mitsushige Sugimoto, MD | |||||
| Senoo Clinic for Internal Medicine and Gastroenterology | Recruiting | ||||
| Hamamatsu, Shizuoka, Japan, 431-3125 | |||||
| Contact: Kazutaka Senoo, MD CBF00628@nifty.com | |||||
| Principal Investigator: Kazutaka Senoo, MD | |||||
| Matsushita Clinic | Recruiting | ||||
| Hamamatsu, Shizuoka, Japan, 433-8121 | |||||
| Contact: Fumiaki Matsushita, MD, PhD 81-53-475-5225 fmatsushita@mail.wbs.ne.jp | |||||
| Principal Investigator: Fumiaki Matsushida, MD, PhD | |||||
| Kumagai Clinic for Internal Medicine and Gastroenterology | Recruiting | ||||
| Hamamatsu, Shizuoka, Japan, 435-0006 | |||||
| Contact: Junichi Kumagai, MD, PhD 81-53-422-2588 jkuma@yr.tnc.ne.jp | |||||
| Principal Investigator: Junichi Kumagai, MD, PhD | |||||
| Nakajima Clinic | Recruiting | ||||
| Kakegawa, Shizuoka, Japan, 436 | |||||
| Contact: Hiroshi Nakamura, MD, PhD 81-537-22-6819 mdnakajima@mail.wbs.ne.jp | |||||
| Principal Investigator: Hiroshi Nakajima, MD, PhD | |||||
| Hamamatsu University |
| Oita University |
| Study Director: | Takahisa Furuta, MD, PhD | Center for Clinical Research, Hamamatsu University School of Medicine |
| Study Director: | Kazunrai Murakami, MD, PhD | Department of Gastroenterology, Oita University Faculty of Medicine |
| Study Chair: | Toshio Fujioka, MD, PhD | Oita University |
More Information
| Study ID Numbers: | Hp.FP-10.01 |
| First Received: | January 23, 2006 |
| Last Updated: | January 26, 2006 |
| ClinicalTrials.gov Identifier: | NCT00281047 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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