The Effect of Berry Extract on Helicobacter Pylori Eradication

January 13, 2010 updated by: Shin Kong Wu Ho-Su Memorial Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chian-Sem Chua, MD
  • Phone Number: 2241 886-2-28332211

Study Locations

  • Taiwan
      • Taipei, Taiwan, 111
        • Recruiting
        • Shin Kong Wu Ho-Su Memorial Hospital
        • Contact:
          • Chian-Sem Chua, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 18

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Use of antibiotics 2 weeks prior to inclusion
  • Previous eradication treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Berry extract
Berry extract for weeks
Placebo Comparator: Berry
Dietary supplement: Berry extract
Berry extract for weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eradication rate
Time Frame: 4 weeks after Eradication of Helicobacter pylori
4 weeks after Eradication of Helicobacter pylori

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Investigators

  • Principal Investigator: Shih-Yi Huang, Ph.D, Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

December 29, 2009

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 13, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SKH-TMU-98-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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