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

Phase 2

• Conditions: Helicobacter Pylori

• Registration Number: NCT00281047
• Lead Sponsor: Hamamatsu University

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.

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 Timeline

• Status Verified: 2006-01
• Study Start: 2006-01
• Study First Submitted: 2006-01-23
• Study First Submitted QC: 2006-01-23
• Study First Posted: 2006-01-24
• Last Update Submitted: 2006-01-26
• Last Update Posted: 2006-01-27
• Study Completion: 2006-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (7)

University Hospital of Hamamatsu University School of Medicine; 🇯🇵 Hamamatsu, Shizuoka, Japan

Oita Kouseiren Tsurumi Hospital; 🇯🇵 Beppu, Oita, Japan

University Hospital of Oita University Faculty of Medicine; 🇯🇵 Oita, Japan

Kumagai Clinic for Internal Medicine and Gastroenterology; 🇯🇵 Hamamatsu, Shizuoka, Japan

Senoo Clinic for Internal Medicine and Gastroenterology; 🇯🇵 Hamamatsu, Shizuoka, Japan

Nakajima Clinic; 🇯🇵 Kakegawa, Shizuoka, Japan

Matsushita Clinic; 🇯🇵 Hamamatsu, Shizuoka, Japan