Mastic Gum and Helicobacter Pylori eradication: an in vivo pilot study
| ISRCTN | ISRCTN01756929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01756929 |
| Secondary identifying numbers | MGHP05 |
- 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
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
| 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 |
| Scientific title | |
| Study 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). |
| 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 |
Eligibility
| 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 inclusion criteria | 1. Patients tested positive for H. pylori 2. Adults of either sex aged between 18 and 75 years of age |
| 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
821-00
Greece
Sponsor information
The Chios Mastic Gum Producers Cooperative (Greece)
Industry
Industry
Konstantinou Monomahou 1
Chios
821-00
Greece
| Website | http://www.gummastic.gr |
|---|---|
"ROR" |
https://ror.org/05rpby975 |
Funders
Funder type
Industry
The Chios Mastic Gum Producers Cooperative (Greece)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
