Determining the effect of Covid 19 vaccine injection on calprotectin levels in patients with intestinal inflammation
Design
Phase 2 quasi-experimental study on 30 patients.
Settings and conduct
In 30 patients with IBD who have a file in the Gastroenterology Center of Isfahan University of Medical Sciences and are under constant monitoring, the level of calprotectin and the level of disease severity will be evaluated and compared before and after the injection of the Covid-19 vaccine. These patients will be monitored one to fifteen days before, and also two weeks and twelve weeks after the vaccination to assess the persistence of inflammation and disease severity after the vaccination, and the relevant tests will be performed.
Participants/Inclusion and exclusion criteria
30 IBD patients registered in the gastrointestinal health clinic who are willing to cooperate in completing the questionnaire and secondary follow-up and are over 18 years old.
Intervention groups
Patients with inflammatory bowel disease are evaluated for calprotectin levels before and after the Covid-19 vaccination.
Main outcome variables
Calprotectin levels; Illness severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210113050024N3
Registration date:2021-09-16, 1400/06/25
Registration timing:prospective
Last update:2021-09-16, 1400/06/25
Update count:0
Registration date
2021-09-16, 1400/06/25
Registrant information
Name
Nazila Kassaian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3237 4705
Email address
nkassaian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of COVID-19 vaccination on calprotectin levels in IBD patients: A quasi-experimental study
Public title
The evaluation of the effect of COVID-19 vaccination on calprotectin levels in IBD patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The IBD patients
Willing to cooperate in completing the questionnaire and secondary follow-up
Be over 18 years old.
Exclusion criteria:
Patient non-cooperation
The patient is in a state of recurrence and has symptoms of bleeding and fever during this period
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-08-30, 1400/06/08
Ethics committee reference number
IR.MUI.MED.REC.1400.417
Health conditions studied
1
Description of health condition studied
Inflammatory Bowel Disease
ICD-10 code
K52
ICD-10 code description
Other and unspecified noninfective gastroenteritis and colitis
Primary outcomes
1
Description
Fecal chlorprotectin levels
Timepoint
The calprotectin level is checked one to fifteen days before the Covid-19 vaccination and also two weeks and twelve weeks after receiving the vaccine.
Method of measurement
Fecal calprotectin levels are assessed using ELISA kits.
2
Description
Illness severity
Timepoint
One to fifteen days before the Covid-19 vaccination and two weeks and twelve weeks after receiving the vaccine.
Method of measurement
Lichtiger and Mayoscore questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with intestinal inflammation who receive the first dose of the Covid-19 vaccine.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Gastroenterology and hepatology Research Center
Full name of responsible person
Babak Tamizifar
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, Gastroenterology and Hepathology Research Center
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3822 2675
Email
babaktamizifar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoi Javanmard
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, Gastroenterology and Hepatology Research Center
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3822 2675
Email
babaktamizifar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
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
Esfahan University of Medical Sciences
Full name of responsible person
Babak Tamizifar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, Gastroenterology and Hepatology Research Center
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3822 2675
Email
babaktamizifar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Tamizifar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Hepatology Research Center, Isfahan University of Medical Sciences, Hezarjerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3822 2675
Email
babaktamizifar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nazila Kassaian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Gastroenterology and Hepatology Research Center, Isfahan University of Medical Sciences, Hezarjerib st.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3822 2675
Email
nkassaian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of the results is allowed in coordination with the executor
From where data/document is obtainable
To receive project documents or data, contact Dr. Babak Tamizifar at:
babaktamizifar@gmail.com
Phone: 00989133257859
What processes are involved for a request to access data/document
Data return is done by written request and acceptance of the conditions by email or phone.