To evaluation of probiotics usage on the intestinal microbiota diversity in patients with celiac disease.
Design
Patients with celiac disease who had been on gluten-free diet for more than one year and were divided into two groups of probiotic or placebo consuming patients and examined for 3 months.
Settings and conduct
The study included two groups: 16 placebo recipients, 15 probiotic recipients under gluten-free diet GFD, Stool samples and blood samples collecting, probiotics and placebo will be prescribed to people with celiac disease 3 times a day for 3 months.
After 3 months, stool and blood samples of individuals with celiac disease will be collected again, DNA extracted from stool samples will be done, Primer pairs will be designed, Real-time-PCR will be Performed, Separation of whole blood serum samples: Data will be analyzed using SPSS software.
Participants/Inclusion and exclusion criteria
patients with CD, aged between 15-90 years, adhering to a strict GFD.
Exclusion criteria were pregnancy, acute or chronic diseases, Crohn، colitis ulcerative، short bowel syndrome disease, consuming alcohol and steroid drugs, ingestion of antibiotics and anti-inflammation nonsteroid drugs at least 1 month prior to study.
Intervention groups
Probiotic and placebo
Main outcome variables
The Effect of Probiotics on the Symptoms of Patients with Celiac Disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171225038063N1
Registration date:2019-10-29, 1398/08/07
Registration timing:registered_while_recruiting
Last update:2019-10-29, 1398/08/07
Update count:0
Registration date
2019-10-29, 1398/08/07
Registrant information
Name
Mona Soheilian Khorzoghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8808 1907
Email address
m.sohailian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-04, 1398/02/14
Expected recruitment end date
2020-05-03, 1399/02/14
Actual recruitment start date
2019-05-04, 1398/02/14
Actual recruitment end date
2020-05-03, 1399/02/14
Trial completion date
2020-05-03, 1399/02/14
Scientific title
Evaluation of probiotic usage on the intestinal microbiota diversity in patiets whith celiac disease; a clinical trial study
Public title
Evaluation of probiotic usage on the intestinal microbiota diversity in patiets whith celiac disease; a clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient under gluten-free diet(GFD)
Confermed having celiac disease based on serology and pathology tests
Exclusion criteria:
Pregnancy
People with the disease Crohn, colitis ulcerative, short bowel syndrome, mouth and stomach surgery, cancer and hepatitis
Use of steroids, antibiotics, and nonsteroidal anti-inflammatory drug 4 weeks before the study
Alcohol consumption
Age
From 15 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
31
Actual sample size reached:
31
Randomization (investigator's opinion)
Randomized
Randomization description
The target population of this study including 31subjects with the celiac disease under gluten-free diet GFD who will be randomly assigned to two groups of probiotics (n = 15) or placebo (n = 16).
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, main investigators, patient care providers, doctors, supervisors, data collectors and people who evaluate the outcome.
Placebo
Used
Assignment
Parallel
Other design features
Use of native probiotics in Iranian patients with celiac disease for the first time
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak Ave,Taleghani Hospital,Tehran
City
Tehran
Province
Tehran
Postal code
1985714711
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.SBMU.RIGLD.REC.1395.114
Health conditions studied
1
Description of health condition studied
Celiac
ICD-10 code
K63.9
ICD-10 code description
Disease of intestine, unspecified
Primary outcomes
1
Description
Fold change in abundance of intestinal Microbiota of patients with celiac disease
Timepoint
3 months
Method of measurement
Real Time PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Probiotic capsule, capsule formulation containing: the Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus strains, each capsule containing 1000000000 colonies, 3 capsules per day, Duration 3 months, produced by the Zist Takhmir company
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule,Capsule formulation containing Fructooligosaccharide as Prebiotic, Lactose, Mg stearate, talc , 3 capsule per day, Duration 3 months ,Product of zist takhmir company
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Mohamad Rostami Nejad
Street address
Yaman st,Velenjak Region, Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985714711
Phone
+98 21 2243 2525
Fax
+98 21 2243 2517
Email
m.rostamii@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad Rostami Nejad
Street address
Yaman St. Velenjak Region, Chamran High Way,
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
m.rostamii@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?