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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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
Other Name: Berry extract
Placebo Comparator: Placebo Dietary Supplement: Berry extract
Berry extract for weeks
Other Name: Berry extract

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045408

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

Locations
Taiwan
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
Investigators
Principal Investigator: Shih-Yi Huang, Ph.D Taipei Medical University
  More Information

No publications provided

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
Study First Received: December 29, 2009
Last Updated: January 13, 2010
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on May 22, 2013