Mastic Gum and Helicobacter Pylori eradication: an in vivo pilot study
| ISRCTN | ISRCTN01756929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01756929 |
| Protocol serial number | MGHP05 |
| Sponsor | The Chios Mastic Gum Producers Cooperative (Greece) |
| Funder | The Chios Mastic Gum Producers Cooperative (Greece) |
- Submission date
- 31/03/2008
- Registration date
- 29/04/2008
- Last edited
- 20/09/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Konstantinos Dabos
Scientific
Scientific
Helenas Venizelou 2
Chios
821-00
Greece
| kostasophia@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial with three arms |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | MGHP |
| Study objectives | 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). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Mastic gum, pantoprazole, amoxicillin, clarithromycin |
| Primary outcome measure(s) |
Eradication of Helicobacter pylori, measured at five weeks after the end of treatment. |
| Key secondary outcome measure(s) |
Helicobacter pylori load in patients remaining H. pylori positive, measured at five weeks after the end of treatment. |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 42 |
| Key inclusion criteria | 1. Patients tested positive for H. pylori 2. Adults of either sex aged between 18 and 75 years of age |
| Key exclusion criteria | 1. Pregnancy 2. Malignancy 3. Allergies to pantoprazole, amoxicillin, clarithromycin |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 01/06/2007 |
Locations
Countries of recruitment
- Greece
Study participating centre
Helenas Venizelou 2
Chios
821-00
Greece
821-00
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2010 | Yes | No |
