Evaluating the protective effects of celiac support capsules in new celiac patients
Design
Phase 2 non-randomized, open-label clinical trial with one group on 12 patients
Settings and conduct
The study will be conducted in Clinics affiliated to Mashhad University of Medical Sciences. Patients suffering from Celiac receive one Celiac Support capsule (every 6 hours) for 3 months 30 minutes before eating a diet containing gluten.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering from celiac disease, not pregnant, age between 5 to 30 years, not suffering from other diseases, normal liver and kidney status
Exclusion criteria: Occurrence of drug allergy, occurrence of clinical symptoms of celiac disease within 48 hours
Intervention groups
Patients suffering from Celiac receive one Celiac Support capsule (every 6 hours) for 3 months 30 minutes before eating a diet containing gluten.
Main outcome variables
Clinical symptoms such as diarrhea, urticaria, abdominal pain and bloating, nausea, vomiting, dyspepsia, abdominal pain, headache, fatigue, skin rashes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038199N17
Registration date:2023-06-22, 1402/04/01
Registration timing:prospective
Last update:2023-06-22, 1402/04/01
Update count:0
Registration date
2023-06-22, 1402/04/01
Registrant information
Name
Vahid Reza Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2264
Email address
askariv941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A pilot study on the safety and effectiveness of celiac support capsule on clinical symptoms in patients suffering from celiac disease
Public title
A pilot study on the celiac support capsule in patients suffering from celiac disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having celiac disease
Age between 5 to 30 years
Not suffering from other diseases
Normal liver and kidney status
Not pregnant
Exclusion criteria:
The occurrence of drug allergy
Occurrence of clinical symptoms of celiac disease within 48 hours
Age
From 5 years old to 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
12
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
Mashhad University of Medical sciences ethical committee
Street address
Faculty medicine, Ferdowsi complex, َVakil Abad Blvd, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.022
Health conditions studied
1
Description of health condition studied
Celiac
ICD-10 code
K90
ICD-10 code description
Intestinal malabsorption
Primary outcomes
1
Description
Clinical symptoms such as diarrhea, urticaria, abdominal pain and bloating, nausea, vomiting, dyspepsia, abdominal pain, headache, fatigue, skin rashes
Timepoint
Weekly
Method of measurement
Checklist
Secondary outcomes
1
Description
Anti-transglutaminase antibody
Timepoint
At the beginning of the study and after 3 months of treatment
Method of measurement
Laboratory kit
2
Description
Antiendomysial antibody
Timepoint
At the beginning of the study and after 3 months of treatment
Method of measurement
Laboratory kit
3
Description
Anti-gliadin antibody (AGA)
Timepoint
At the beginning of the study and after 3 months of treatment
Method of measurement
Laboratory kit
4
Description
Intraepithelial lymphocytes (IEL)
Timepoint
At the beginning of the study and after 3 months of treatment
Method of measurement
Laboratory kit
Intervention groups
1
Description
Intervention group: Celiac patients receive 1 Celiac Support capsule (every 6 hours) for 3 months 30 minutes before eating a diet containing gluten.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affiliated to Mashhad University of Medical Sciences
Full name of responsible person
Dr Vahid Reza Askari
Street address
Mashhad University of Medical Science, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
askariv@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayour-Mobarhan
Street address
Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available