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The Influence of FP-10 on the Eradication Rates of H. Pylori by a Triple Therapy

This study is currently recruiting participants.
Verified by Hamamatsu University, January 2006

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   

U.S. FDA Resources

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

Further study details as provided by Hamamatsu University:

Primary Outcome Measures:
  • The effect of FP-01 on the eradication rates of H. pylori infection by a triple therapy

Secondary Outcome Measures:
  • The effect o FP-10 on the eradication rates of clarithromycin-sensitive and -resistant strains of H. pylori by a triple therapy

Estimated Enrollment:   138
Study Start Date:   January 2006
Estimated Study Completion Date:   May 2006

Detailed Description:

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

Criteria

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

-

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281047

Contacts
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    

Locations
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            

Sponsors and Collaborators
Hamamatsu University
Oita University

Investigators
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

Publications:
Furuta T, Sagehashi Y, Shirai N, Sugimoto M, Nakamura A, Kodaira M, Kenmotsu K, Nagano M, Egashira T, Ueda K, Yoneyama M, Ohashi K, Ishizaki T, Hishida A. Influence of CYP2C19 polymorphism and Helicobacter pylori genotype determined from gastric tissue samples on response to triple therapy for H pylori infection. Clin Gastroenterol Hepatol. 2005 Jun;3(6):564-73.
 
Shirai N, Furuta T, Sugimoto M, Nakamura A. [High dose dual PPI/AMPC therapy for the treatment of Helicobacter pylori infection after failure of usual standard triple PPI/AMPC/CAM therapy] Nippon Rinsho. 2005 Nov;63 Suppl 11:438-41. Japanese. No abstract available.
 
Okudaira K, Miura S, Furuta T, Sugimoto M, Shirai N. [Concomitant dosing of a H2 receptor antagonist (H2RA) with a triple therapy increases the cure rate of Helicobacter pylori infection] Nippon Rinsho. 2005 Nov;63 Suppl 11:391-6. Japanese. No abstract available.
 
Furuta T, Shirai N, Sugimoto M, Nakamura A, Hishida A, Ishizaki T. Influence of CYP2C19 pharmacogenetic polymorphism on proton pump inhibitor-based therapies. Drug Metab Pharmacokinet. 2005 Jun;20(3):153-67.
 
Furuta T, Shirai N, Sugimoto M, Nakamura A, Okudaira K, Kajimura M, Hishida A. Effect of concomitant dosing of famotidine with lansoprazole on gastric acid secretion in relation to CYP2C19 genotype status. Aliment Pharmacol Ther. 2005 Jul 1;22(1):67-74.
 
Okudaira K, Furuta T, Shirai N, Sugimoto M, Miura S. Concomitant dosing of famotidine with a triple therapy increases the cure rates of Helicobacter pylori infections in patients with the homozygous extensive metabolizer genotype of CYP2C19. Aliment Pharmacol Ther. 2005 Feb 15;21(4):491-7. Erratum in: Aliment Pharmacol Ther. 2005 Jun 1;21(11):1398.
 
Murakami K, Fujioka T. [Drug resistant H. pylori in Japan: general remarks] Nippon Rinsho. 2005 Nov;63 Suppl 11:198-202. Japanese. No abstract available.
 
Murakami K, Kodama M, Sato R, Okimoto T, Watanabe K, Fujioka T. Helicobacter pylori eradication and associated changes in the gastric mucosa. Expert Rev Anti Infect Ther. 2005 Oct;3(5):757-64.
 
Murakami K, Sato R, Okimoto T, Watanabe K, Nasu M, Fujioka T, Kodama M, Kagawa J. Influence of anti-ulcer drugs used in Japan on the result of (13)C-urea breath test for the diagnosis of Helicobacter pylori infection. J Gastroenterol. 2003;38(10):937-41.
 
Hiramoto S, Itoh K, Shizuuchi S, Kawachi Y, Morishita Y, Nagase M, Suzuki Y, Nobuta Y, Sudou Y, Nakamura O, Kagaya I, Goshima H, Kodama Y, Icatro FC, Koizumi W, Saigenji K, Miura S, Sugiyama T, Kimura N. Melanoidin, a food protein-derived advanced maillard reaction product, suppresses Helicobacter pylori in vitro and in vivo. Helicobacter. 2004 Oct;9(5):429-35.
 
Murakami K, Sato R, Okimoto T, Nasu M, Fujioka T, Kodama M, Kagawa J. Efficacy of triple therapy comprising rabeprazole, amoxicillin and metronidazole for second-line Helicobacter pylori eradication in Japan, and the influence of metronidazole resistance. Aliment Pharmacol Ther. 2003 Jan;17(1):119-23.
 
Murakami K, Sato R, Okimoto T, Nasu M, Fujioka T, Kodama M, Kagawa J, Sato S, Abe H, Arita T. Eradication rates of clarithromycin-resistant Helicobacter pylori using either rabeprazole or lansoprazole plus amoxicillin and clarithromycin. Aliment Pharmacol Ther. 2002 Nov;16(11):1933-8.
 
Murakami K, Nasu M. [Clarithromycin (CAM)] Nippon Rinsho. 2002 Feb;60 Suppl 2:667-70. Review. Japanese. No abstract available.
 
Murakami K, Nasu M. [Drug sensitivity test for Helicobacter pylori] Nippon Rinsho. 2002 Feb;60 Suppl 2:350-3. Review. Japanese. No abstract available.
 
Murakami K, Fujioka T, Okimoto T, Sato R, Kodama M, Nasu M. Drug combinations with amoxycillin reduce selection of clarithromycin resistance during Helicobacter pylori eradication therapy. Int J Antimicrob Agents. 2002 Jan;19(1):67-70.
 
Asaka M, Satoh K, Sugano K, Sugiyama T, Takahashi S, Fukuda Y, Ota H, Murakami K, Kimura K, Shimoyama T. Guidelines in the management of Helicobacter pylori infection in Japan. Helicobacter. 2001 Sep;6(3):177-86.
 
Murakami K, Fujioka T, Kodama R, Kubota T, Tokieda M, Nasu M. Helicobacter pylori infection accelerates human gastric mucosal cell proliferation. J Gastroenterol. 1997 Apr;32(2):184-8.
 

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

Keywords provided by Hamamatsu University:
Helicobacter pylori (H. pylori)  
FP-10  
amoxicillin  
clarithromycin  
lansoprazole  

Study placed in the following topic categories:
Clarithromycin
Caseins
Amoxicillin
Lansoprazole

Additional relevant MeSH terms:
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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