Contact information
Type
Scientific
Contact name
Dr Konstantinos Dabos
ORCID ID
Contact details
Helenas Venizelou 2
Chios
821-00
Greece
kostasophia@yahoo.com
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Mastic gum, pantoprazole, amoxicillin, clarithromycin
Primary outcome measure
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 study start date
01/12/2006
Overall study end date
01/06/2007
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
75 Years
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2010 | Yes | No |