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The Effect of Berry Extract on Helicobacter Pylori Eradication

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ClinicalTrials.gov Identifier: NCT01045408
Recruitment Status : Unknown
Verified January 2010 by Shin Kong Wu Ho-Su Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : January 11, 2010
Last Update Posted : January 14, 2010
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Increase the Eradication Rate of Helicobacter Pylori Dietary Supplement: Berry extract Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Adjuvant Effect of Berry Extract on Triple Therapy for Helicobacter Pylori Eradication
Study Start Date : January 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : June 2010
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Berry Dietary Supplement: Berry extract
Berry extract for weeks
Placebo Comparator: Placebo Dietary Supplement: Berry extract
Berry extract for weeks

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01045408     History of Changes
Other Study ID Numbers: SKH-TMU-98-02
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010

Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
Helicobacter pylori
Berry extract
Triple therapy