NCT01045408

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

Enrollment Period

11 months

First QC Date

December 29, 2009

Last Update Submit

January 13, 2010

Conditions

Increase the Eradication Rate of Helicobacter Pylori

Keywords

Helicobacter pyloriBerry extractTriple therapy

Outcome Measures

Primary Outcomes (1)

  • Eradication rate

    4 weeks after Eradication of Helicobacter pylori

Study Arms (2)

Berry

PLACEBO COMPARATOR
Dietary Supplement: Berry extract

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Berry extract

Interventions

Berry extractDIETARY_SUPPLEMENT

Berry extract for weeks

BerryPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18

You may not qualify if:

  • Pregnancy or breastfeeding
  • Previous eradication treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

RECRUITING

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Shih-Yi Huang, Ph.D

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chian-Sem Chua, MD

CONTACT

886-2-28332211

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 29, 2009

First Posted

January 11, 2010

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations

TW(1)