To assess the safety and efficacy of Cornelian cherry in the treatment of intestinal metaplasia
Design
non-randomized, pilot study on 30 patients; no control group will be assessed since gastric intestinal metaplasia has no pre-approved treatment.
Settings and conduct
the study is neither blinded nor randomized. the study will be conducted in gastroenterology clinics of shiraz university of medical sciences.
Participants/Inclusion and exclusion criteria
Adult patients older than ۲۰ years old with intestinal metaplasia who are referred to gastroenterology clinics of Shiraz University of Medical Sciences will be included in our study. The exclusion criteria will be: patients younger than ۲۰ years old, pregnancy, lactation, the existence of gastric cancer, calcium oxalate nephrolithiasis, and the history of any surgical interventions performed on the stomach such as Billroth I and II
Intervention groups
after treatment of H.pylori infection, the patients with GIM will be asked to consume ۵۰ Cornelian cherries (one cup) each day for two months. the patients will undergo upper endoscopy before and after the treatment
Main outcome variables
the existence of gastric intestinal metaplasia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230811059114N1
Registration date:2023-08-23, 1402/06/01
Registration timing:registered_while_recruiting
Last update:2023-08-23, 1402/06/01
Update count:0
Registration date
2023-08-23, 1402/06/01
Registrant information
Name
Seyyed Mohammad Kazem Hosseiniasl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 793 3211
Email address
kazemhosseiniasl@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the safety and efficacy of Cornelian cherry in the treatment of gastric intestinal metaplasia a pilot study
Public title
Cornelian Cherry in Gastric Intestinal Metaplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients older than ۲۰ years old
with intestinal metaplasia
who are referred to gastroenterology clinics of Shiraz University of Medical Sciences
Exclusion criteria:
patients younger than ۲۰ years old
pregnancy
lactation
existence of gastric cancer
calcium oxalate nephrolithiasis
history of any surgical interventions performed on the stomach such as Billroth I and II
Age
From 20 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
9th floor, building No.2, School of Medicine, Zand St., Shiraz, Iran
City
shiraz
Province
Fars
Postal code
7134845794
Approval date
2023-02-21, 1401/12/02
Ethics committee reference number
IR.SUMS.MED.REC.1401.569
Health conditions studied
1
Description of health condition studied
gastric intestinal metaplasia
ICD-10 code
K31.9
ICD-10 code description
Disease of stomach and duodenum, unspecified
Primary outcomes
1
Description
the existence of gastric intestinal metaplasia in histopathologic samples
Timepoint
before intervention and two months and one year after intervention
Method of measurement
histopathologic samples of biopsies taken through endoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving 50 (one cup) cornelian cherry each day for two months, half of which with lunch and the other half with dinner
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinics of Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohammad Kazem Hosseini-Asl
Street address
Department of Internal Medicine, Namazi Hospital, Namazi sq., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Fax
Email
kazemhosseiniasl@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
Deputy of Research and Technology, seventh floor, central building of Shiraz University of Medical Sciences, Zand st., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohammad Kazem Hosseini-Asl
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Department of Internal Medicine, Namazi hospital, Namazi sq., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
kazemhosseiniasl@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohammad Kazem Hosseini-Asl
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Department of Internal Medicine, Namazi Hospital, Namazi Sq., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
kazemhosseiniasl@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Mohammad Kazem Hosseini-Asl
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Department of Internal Medicine, Namazi Hospital, Namazi Sq., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
kazemhosseiniasl@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
the patients' information will be reported after the study as cumulative data and after they will have been made anonymous
When the data will become available and for how long
after the study which will take about one and a half year
To whom data/document is available
all of the researchers
Under which criteria data/document could be used
upon reasonable request, the researchers can ask for the data after they will have been made anonymous
From where data/document is obtainable
the article will be published and the data can be accessed through email of the corresponding author
What processes are involved for a request to access data/document
after indicating the reason why they want the data and their identity the data will be available to them which will take less than a week