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The Effect of Berry Extract on Helicobacter Pylori Eradication

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Shin Kong Wu Ho-Su Memorial Hospital.
Recruitment status was:  Recruiting
Information provided by:
Shin Kong Wu Ho-Su Memorial Hospital Identifier:
First received: December 29, 2009
Last updated: January 13, 2010
Last verified: January 2010
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.

Condition Intervention Phase
Increase the Eradication Rate of Helicobacter Pylori
Dietary Supplement: Berry extract
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Adjuvant Effect of Berry Extract on Triple Therapy for Helicobacter Pylori Eradication

Further study details as provided by Shin Kong Wu Ho-Su Memorial Hospital:

Primary Outcome Measures:
  • Eradication rate [ Time Frame: 4 weeks after Eradication of Helicobacter pylori ]

Estimated Enrollment: 120
Study Start Date: January 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Berry Dietary Supplement: Berry extract
Berry extract for weeks
Placebo Comparator: Placebo Dietary Supplement: Berry extract
Berry extract for weeks

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients older than 18

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Use of antibiotics 2 weeks prior to inclusion
  • Previous eradication treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01045408

Contact: Chian-Sem Chua, MD 886-2-28332211 ext 2241

Shin Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan, 111
Contact: Chian-Sem Chua, MD         
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Principal Investigator: Shih-Yi Huang, Ph.D Taipei Medical University
  More Information

Responsible Party: HUNG,CHI-JEN, Shin Kong Wu Ho-Su Memorial Hospital Identifier: NCT01045408     History of Changes
Other Study ID Numbers: SKH-TMU-98-02
Study First Received: December 29, 2009
Last Updated: January 13, 2010

Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
Helicobacter pylori
Berry extract
Triple therapy processed this record on May 23, 2017