Condition category
Infections and Infestations
Date applied
31/03/2008
Date assigned
29/04/2008
Last edited
20/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Konstantinos Dabos

ORCID ID

Contact details

Helenas Venizelou 2
Chios
821-00
Greece
kostasophia@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MGHP05

Study information

Scientific title

Acronym

MGHP

Study hypothesis

Mastic gum is effective in eradicating Helicobacter pylori in vivo.

Ethics approval

Ethics approval received from the Greek Medicines Agency Ethics Board on the 18th December 2005 (ref: MGCGH0032/06).

Study design

Randomised controlled trial with three arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Helicobacter pylori gastritis

Intervention

Patients positive to Helicobacter pylori will be randomised to receive one of the following:

1. Mastic gum 2 g per day for 14 days
2. Mastic gum 2 g per day and pantoprazole 40 mg per day for 14 days
3. Pantoprazole 40 mg per day, amoxicillin 2 g per day and clarithromycin 1 g per day for 10 days

Follow up was two months after the end of the treatment for all study arms.

Intervention type

Drug

Phase

Not Specified

Drug names

Mastic gum, pantoprazole, amoxicillin, clarithromycin

Primary outcome measures

Eradication of Helicobacter pylori, measured at five weeks after the end of treatment.

Secondary outcome measures

Helicobacter pylori load in patients remaining H. pylori positive, measured at five weeks after the end of treatment.

Overall trial start date

01/12/2006

Overall trial end date

01/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients tested positive for H. pylori
2. Adults of either sex aged between 18 and 75 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

1. Pregnancy
2. Malignancy
3. Allergies to pantoprazole, amoxicillin, clarithromycin

Recruitment start date

01/12/2006

Recruitment end date

01/06/2007

Locations

Countries of recruitment

Greece

Trial participating centre

Helenas Venizelou 2
Chios
821-00
Greece

Sponsor information

Organisation

The Chios Mastic Gum Producers Cooperative (Greece)

Sponsor details

Konstantinou Monomahou 1
Chios
821-00
Greece

Sponsor type

Industry

Website

http://www.gummastic.gr

Funders

Funder type

Industry

Funder name

The Chios Mastic Gum Producers Cooperative (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19879118

Publication citations

  1. Results

    Dabos KJ, Sfika E, Vlatta LJ, Giannikopoulos G, The effect of mastic gum on Helicobacter pylori: a randomized pilot study., Phytomedicine, 2010, 17, 3-4, 296-299, doi: 10.1016/j.phymed.2009.09.010.

Additional files

Editorial Notes