The Effect of Berry Extract on Helicobacter Pylori Eradication

Sponsor

Shin Kong Wu Ho-Su Memorial Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01045408

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jan 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Jun 1, 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

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

Eradication rate [4 weeks after Eradication of Helicobacter pylori]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Shin Kong Wu Ho-Su Memorial Hospital	Taipei		Taiwan	111

Sponsors and Collaborators

Shin Kong Wu Ho-Su Memorial Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01045408

Other Study ID Numbers:

SKH-TMU-98-02

First Posted:

Jan 11, 2010

Last Update Posted:

Jan 14, 2010

Last Verified:

Jan 1, 2010

Keywords provided by , ,

Helicobacter pylori

Berry extract

Triple therapy

Study Results

No Results Posted as of Jan 14, 2010