Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2006 by Hamamatsu University.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Oita University
Information provided by:
Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00281047
First received: January 23, 2006
Last updated: January 26, 2006
Last verified: January 2006
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Oita Kouseiren Tsurumi Hospital
Beppu, Oita, Japan, 874-8585
Senoo Clinic for Internal Medicine and Gastroenterology
Hamamatsu, Shizuoka, Japan, 431-3125
University Hospital of Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan, 431-3192
Matsushita Clinic
Hamamatsu, Shizuoka, Japan, 433-8121
Kumagai Clinic for Internal Medicine and Gastroenterology
Hamamatsu, Shizuoka, Japan, 435-0006
Nakajima Clinic
Kakegawa, Shizuoka, Japan, 436
University Hospital of Oita University Faculty of Medicine
Oita, Japan, 879-5593
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:

ClinicalTrials.gov Identifier: NCT00281047     History of Changes
Other Study ID Numbers: Hp.FP-10.01 
Study First Received: January 23, 2006
Last Updated: January 26, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Amoxicillin
Clarithromycin
Lansoprazole
Dexlansoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 08, 2016