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

NCT00281047 | Unknown Phase 2

• 1 other identifier: Hp.FP-10.01
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Helicobacter Pylori

Keywords

Helicobacter pylori (H. pylori); FP-10; amoxicillin; clarithromycin; lansoprazole

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

FP-10 DRUG

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• H. pylori-positive patients who have never undergo the H. pylori eradication therapy -

You may not qualify if:

• Patients not infected with H. pylori, Patients who are allergic to amoxicillin, clarithromycin, lansoprazole, 13C-urea, or milk casein

Sponsors & Collaborators

• Hamamatsu University: lead
• Oita University: collaborator

Study Sites (7)

Oita Kouseiren Tsurumi Hospital

Beppu, Oita Prefecture, 874-8585, Japan

RECRUITING

University Hospital of Oita University Faculty of Medicine

Ōita, Oita Prefecture, 879-5593, Japan

RECRUITING

Senoo Clinic for Internal Medicine and Gastroenterology

Hamamatsu, Shizuoka, 431-3125, Japan

RECRUITING

University Hospital of Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

RECRUITING

Matsushita Clinic

Hamamatsu, Shizuoka, 433-8121, Japan

RECRUITING

Kumagai Clinic for Internal Medicine and Gastroenterology

Hamamatsu, Shizuoka, 435-0006, Japan

RECRUITING

Nakajima Clinic

Kakegawa, Shizuoka, 436, Japan

RECRUITING

Related Publications (17)

• 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. doi: 10.1016/s1542-3565(04)00779-7.

  PMID: 15952098 BACKGROUND

• 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]. Nihon Rinsho. 2005 Nov;63 Suppl 11:438-41. No abstract available. Japanese.

  PMID: 16363575 BACKGROUND

• 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]. Nihon Rinsho. 2005 Nov;63 Suppl 11:391-6. No abstract available. Japanese.

  PMID: 16363566 BACKGROUND

• 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. doi: 10.2133/dmpk.20.153.

  PMID: 15988117 BACKGROUND

• 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. doi: 10.1111/j.1365-2036.2005.02523.x.

  PMID: 15963082 BACKGROUND

• 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. doi: 10.1111/j.1365-2036.2005.02353.x.

  PMID: 15710002 BACKGROUND

• Murakami K, Fujioka T. [Drug resistant H. pylori in Japan: general remarks]. Nihon Rinsho. 2005 Nov;63 Suppl 11:198-202. No abstract available. Japanese.

  PMID: 16363531 BACKGROUND

• 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. doi: 10.1586/14787210.3.5.757.

  PMID: 16207167 BACKGROUND

• 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. doi: 10.1007/s00535-003-1176-x.

  PMID: 14614600 BACKGROUND

• 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. doi: 10.1111/j.1083-4389.2004.00263.x.

  PMID: 15361082 BACKGROUND

• 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. doi: 10.1046/j.1365-2036.2003.01401.x.

  PMID: 12492740 BACKGROUND

• 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. doi: 10.1046/j.1365-2036.2002.01368.x.

  PMID: 12390102 BACKGROUND

• Murakami K, Nasu M. [Clarithromycin (CAM)]. Nihon Rinsho. 2002 Feb;60 Suppl 2:667-70. No abstract available. Japanese.

  PMID: 11979867 BACKGROUND

• Murakami K, Nasu M. [Drug sensitivity test for Helicobacter pylori]. Nihon Rinsho. 2002 Feb;60 Suppl 2:350-3. No abstract available. Japanese.

  PMID: 11979806 BACKGROUND

• 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. doi: 10.1016/s0924-8579(01)00456-3.

  PMID: 11814770 BACKGROUND

• 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. doi: 10.1046/j.1523-5378.2001.00027.x.

  PMID: 11683920 BACKGROUND

• 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. doi: 10.1007/BF02936365.

  PMID: 9085165 BACKGROUND

Study Officials

• 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 DIRECTOR

• Toshio Fujioka, MD, PhD

  Oita University

  STUDY CHAIR

Central Study Contacts

Takahisa Furuta, MD, PhD

CONTACT

81-53-435-2850; furuta@hama-med.ac.jp

Kazunari Murakami, MD, PhD

CONTACT

81-97-586-6193; murakam@med.oita-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 23, 2006
• First Posted: January 24, 2006
• Study Start: January 1, 2006
• Study Completion: May 1, 2006
• Last Updated: January 27, 2006

Record last verified: 2006-01

Locations

JP (7)