Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281047
Status:
UNKNOWN
Last Update Posted:
2006-01-27
First Post:
2006-01-23
Brief Title:
The Influence of FP-10 on the Eradication Rates of H Pylori by a Triple Therapy
Sponsor:
Hamamatsu University
Organization:
Hamamatsu University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None