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

Sponsor

Hamamatsu University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00281047

Collaborator

Oita University (Other)

138

Enrollment

Locations

3.9

Duration (Months)

19.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori	Drug: FP-10	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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

Study Start Date :

Jan 1, 2006

Study Completion Date :

May 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Locations

	Site	City	State	Country	Postal Code
1	Oita Kouseiren Tsurumi Hospital	Beppu	Oita	Japan	874-8585
2	Senoo Clinic for Internal Medicine and Gastroenterology	Hamamatsu	Shizuoka	Japan	431-3125
3	University Hospital of Hamamatsu University School of Medicine	Hamamatsu	Shizuoka	Japan	431-3192
4	Matsushita Clinic	Hamamatsu	Shizuoka	Japan	433-8121
5	Kumagai Clinic for Internal Medicine and Gastroenterology	Hamamatsu	Shizuoka	Japan	435-0006
6	Nakajima Clinic	Kakegawa	Shizuoka	Japan	436
7	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