The aim of present study was to examine the effects of Taurine on clinical signs/symptoms and laboratory tests of ulcerative colitis patients.
The study is a randomized and will be performed in a single center.
Patients of both sexes (18 to 60 year old) who are newly diagnosed with ulcerative colitis and are in their first month of therapy or those who are not controlled with existing therapies will be invited to the study. Diagnosis and expansion of disease will be determined according to clinical symptoms and endoscopic examination. Exclusion criteria will be pregnant women; presence of disease for less than 2 weeks; crohn's disease patients; patients who receive supplements; patients with systemic disease (tumor or perforation), other inflammatory disease or history of surgery.
100 patients will be selected randomly and will be divided into two groups using Random Allocation software. 50 of these patients will receive 1g/day Taurine capsules for 8 weeks in addition to their routine treatment (Intervention group). Other 50 patients will receive routine treatment (Control group).
Patients clinical signs/symptoms and quality of life will be recorded in a questionnaire. Laboratory parameters of CBC, ESR,CRP and measurement of Cytokines (TNF-alfa, IL1b and IL6) and taurine concentration in serum will be measured using available methods. These factors will be compared between two groups at the beginning of the study and after 8 weeks of starting the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101275704N1
Registration date:2011-04-26, 1390/02/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-04-26, 1390/02/06
Registrant information
Name
Simin Ozar Mashayekhi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 2250
Email address
mashayekhis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences (Liver and Gastrointestinal disease research center)
Expected recruitment start date
2011-05-05, 1390/02/15
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Taurine on clinical symptoms and laboratory parameters of ulcerative colitis patients.
Public title
Effects of Taurine on treatment process of ulcerative colitis patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients of both sex, who are recently diagnosed with ulcerative colitis and are being treated for a maximum of 1 month; or their disease is not controlled by routine treatments.
Exclusion criteria:pregnant women; presence of signs and symptoms for less than 2 weeks; diagnosed with crohn's disease; patients who receive supplements; patients with systemic disease such as tumor or perforation; patients with other inflammatory disease or history of surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics Committee of Tabriz University of medical Sciences
Street address
Vice Chancellor of Tabriz University of Medical Science, 2nd main Building, Daneshgah St.
City
Tabriz
Postal code
5166414766
Approval date
2011-04-18, 1390/01/29
Ethics committee reference number
746/4/5
Health conditions studied
1
Description of health condition studied
ulcerative colitis
ICD-10 code
K-51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Disease signs and symptoms
Timepoint
Prior to intervention and 8 weeks after intervention
Prior to intervention and 8 weeks after intervention
Method of measurement
ELISA
2
Description
interleukin (IL)-6 serum concentration
Timepoint
Prior to intervention and 8 weeks after intervention
Method of measurement
ELISA
3
Description
C-Reactive Protein
Timepoint
Prior to intervention and 8 weeks after intervention
Method of measurement
Available and tested methods
4
Description
erythrocyte sedimentation rate (ESR)
Timepoint
Prior to intervention and 8 weeks after intervention
Method of measurement
Available and tested methods
5
Description
interleukin (IL)-1b serum concentration
Timepoint
Prior to intervention and 8 weeks after intervention
Method of measurement
ELISA
6
Description
taurine concentration in serum
Timepoint
Prior to intervention and 8 weeks after intervention
Method of measurement
HPLC
7
Description
Serum Albumin concentration
Timepoint
Prior to intervention and 8 weeks after intervention
Method of measurement
Available and tested methods
8
Description
Quality of life
Timepoint
Prior to intervention and 8 weeks after intervention
Method of measurement
Questionaire
Intervention groups
1
Description
The intervention group will receive 1 g taurine every day for 8 weeks in addition to their routine treatment and the mentioned outcome will be evaluated at time zero and 8 weeks later.
Taurine is an amino acid which is commonly found in sea foods and energy drinks. Each of our patients will receive 1 g taurine (as capsule) each day for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group will receive routine treatment and the mentioned outcomes will be evaluated at time zero and 8 weeks later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykh-o-alrais medical center
Full name of responsible person
Niko Seraji; paria Habiballahi
Street address
Azadi St, between Jodeyri and Gholgasht St
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences (Liver and Gastrointestinal di
Full name of responsible person
Dr Mohammadreza Rashidi
Street address
Vice Chancellor for research of Tabriz University of Medical Science, 2nd main Building, Daneshgah St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tabriz University of Medical Sciences (Liver and Gastrointestinal di
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Simin Mashayekhi
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Daneshgah St,
City
Tabriz
Postal code
5166414766
Phone
+98 41 1337 2250
Fax
+98 41 1334 4798
Email
mashayekhis@yahoo.co.uk; mashayekhis@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Simin Mashayekhi
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Daneshgah St,
City
Tabriz
Postal code
5166414766
Phone
+98 411337225
Fax
+98 41 1334 4798
Email
mashayekhis@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Simin Mashayekhi
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Daneshgah St
City
Tabriz
Postal code
5166414766
Phone
+98 41 1337 2250
Fax
+98 41 1334 4798
Email
mashayekhis@yahoo.co.uk
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)