The Effect of Berry Extract on Helicobacter Pylori Eradication

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Shin Kong Wu Ho-Su Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01045408
First received: December 29, 2009
Last updated: January 13, 2010
Last verified: January 2010

December 29, 2009
January 13, 2010
January 2009
December 2009   (final data collection date for primary outcome measure)
Eradication rate [ Time Frame: 4 weeks after Eradication of Helicobacter pylori ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01045408 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Berry Extract on Helicobacter Pylori Eradication
The Adjuvant Effect of Berry Extract on Triple Therapy for Helicobacter Pylori Eradication

Helicobacter pylori (HP) is the major risk factors of gastritis, gastric ulcers, duodenal ulcers, mucosa associated lymphoid tissue lymphoma and gastric cancer. Helicobacter pylori are found in 70-90% of the population in developing countries and in 25-50% of developed countries.

One-week of triple therapy composed of a proton pump inhibitor plus two antibiotics is currently regarded as the gold standard for HP eradication. However, the eradication rate continues to be disappointing. Poor patient compliance and bacterial resistance are the main factors contributing to treatment failure. Therefore, it is urgently necessary to develop a non-antibiotic alternative therapy to increase the eradication rates of Helicobacter pylori. Some literatures reported that cranberry may inhibit Helicobacter pylori adhesion to the human gastric mucus and may reduce Helicobacter pylori infection in adults. The aims of his experiment were to explore the impact of berry extract on triple therapy for Helicobacter pylori eradication.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Increase the Eradication Rate of Helicobacter Pylori
Dietary Supplement: Berry extract
Berry extract for weeks
Other Name: Berry extract
  • Placebo Comparator: Berry
    Intervention: Dietary Supplement: Berry extract
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Berry extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients older than 18

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Use of antibiotics 2 weeks prior to inclusion
  • Previous eradication treatment
Both
18 Years and older
No
Contact: Chian-Sem Chua, MD 886-2-28332211 ext 2241
Taiwan
 
NCT01045408
SKH-TMU-98-02
Yes
HUNG,CHI-JEN, Shin Kong Wu Ho-Su Memorial Hospital
Shin Kong Wu Ho-Su Memorial Hospital
Not Provided
Principal Investigator: Shih-Yi Huang, Ph.D Taipei Medical University
Shin Kong Wu Ho-Su Memorial Hospital
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP