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

Helicobacter Pylori Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00281047
• Other study ID #: Hp.FP-10.01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 23, 2006
• Last updated: January 26, 2006
• Start date: January 2006
• Est. completion date: May 2006

Study information

• Verified date: January 2006
• Source: Hamamatsu University
• Contact: Takahisa Furuta, MD, PhD
• Phone: 81-53-435-2850
• Email: furuta[@]hama-med.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Pylori

Intervention

Drug:
• FP-10

Locations

Country	Name	City	State
Japan	Oita Kouseiren Tsurumi Hospital	Beppu	Oita
Japan	Kumagai Clinic for Internal Medicine and Gastroenterology	Hamamatsu	Shizuoka
Japan	Matsushita Clinic	Hamamatsu	Shizuoka
Japan	Senoo Clinic for Internal Medicine and Gastroenterology	Hamamatsu	Shizuoka
Japan	University Hospital of Hamamatsu University School of Medicine	Hamamatsu	Shizuoka
Japan	Nakajima Clinic	Kakegawa	Shizuoka
Japan	University Hospital of Oita University Faculty of Medicine	Oita

Sponsors (2)

Lead Sponsor	Collaborator
Hamamatsu University	Oita University

Country where clinical trial is conducted

Japan, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Murakami K, Fujioka T. [Drug resistant H. pylori in Japan: general remarks]. Nihon Rinsho. 2005 Nov;63 Suppl 11:198-202. Review. Japanese. — View Citation

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. Review. — View Citation

Murakami K, Nasu M. [Clarithromycin (CAM)]. Nihon Rinsho. 2002 Feb;60 Suppl 2:667-70. Review. Japanese. — View Citation

Murakami K, Nasu M. [Drug sensitivity test for Helicobacter pylori]. Nihon Rinsho. 2002 Feb;60 Suppl 2:350-3. Review. Japanese. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Japanese. — View Citation

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. Review. Japanese. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of FP-01 on the eradication rates of H. pylori infection by a triple therapy
Secondary	The effect o FP-10 on the eradication rates of clarithromycin-sensitive and -resistant strains of H. pylori by a triple therapy