The Influence of FP-10 on the Eradication Rates of H. Pylori by a Triple Therapy
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
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|
- The effect of FP-01 on the eradication rates of H. pylori infection by a triple therapy
- The effect o FP-10 on the eradication rates of clarithromycin-sensitive and -resistant strains of H. pylori by a triple therapy
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||May 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281047
|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|
|Hamamatsu, Shizuoka, Japan, 433-8121|
|Kumagai Clinic for Internal Medicine and Gastroenterology|
|Hamamatsu, Shizuoka, Japan, 435-0006|
|Kakegawa, Shizuoka, Japan, 436|
|University Hospital of Oita University Faculty of Medicine|
|Oita, Japan, 879-5593|
|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|