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

January 26, 2006 updated by: Hamamatsu University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

138

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Oita, Japan, 879-5593
        • Recruiting
        • University Hospital of Oita University Faculty of Medicine
        • Contact:
        • Principal Investigator:
          • Kazunari Murakami, MD, PhD
    • Oita
      • Beppu, Oita, Japan, 874-8585
        • Recruiting
        • Oita Kouseiren Tsurumi Hospital
        • Contact:
        • Principal Investigator:
          • Takayuki Nagai, MD, PhD
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3125
        • Recruiting
        • Senoo Clinic for Internal Medicine and Gastroenterology
        • Contact:
        • Principal Investigator:
          • Kazutaka Senoo, MD
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Recruiting
        • University Hospital of Hamamatsu University School of Medicine
        • Contact:
        • Principal Investigator:
          • Takahisa Furuta, MD, PhD
        • Sub-Investigator:
          • Naohito Shirai, MD, PhD
        • Sub-Investigator:
          • Mitsushige Sugimoto, MD
      • Hamamatsu, Shizuoka, Japan, 433-8121
        • Recruiting
        • Matsushita Clinic
        • Contact:
        • Principal Investigator:
          • Fumiaki Matsushida, MD, PhD
      • Hamamatsu, Shizuoka, Japan, 435-0006
        • Recruiting
        • Kumagai Clinic for Internal Medicine and Gastroenterology
        • Contact:
        • Principal Investigator:
          • Junichi Kumagai, MD, PhD
      • Kakegawa, Shizuoka, Japan, 436
        • Recruiting
        • Nakajima Clinic
        • Contact:
        • Principal Investigator:
          • Hiroshi Nakajima, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamamatsu University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

January 23, 2006

First Submitted That Met QC Criteria

January 23, 2006

First Posted (Estimate)

January 24, 2006

Study Record Updates

Last Update Posted (Estimate)

January 27, 2006

Last Update Submitted That Met QC Criteria

January 26, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Hp.FP-10.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Helicobacter Pylori

Clinical Trials on FP-10

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe