The aim of this study was to evaluate effectiveness of probiotic in the treatment of gastrointestinal symptoms in patients with scleroderma who referred to Imam Khomeini hospital in 2014. In this clinical trial, 37 patients with systemic sclerosis with moderate to severe symptoms were divided randomly in two intervention and control groups. The probiotic was given to intervention group and placebo to control group which similar to probiotic. Inventory (UCLA SCTC GIT 2.0) was used for rating the severity of the gastrointestinal tract. The efficacy of probiotic in treatment of gastrointestinal symptoms was measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120618142N2
Registration date:2015-12-25, 1394/10/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-25, 1394/10/04
Registrant information
Name
Firouz Amani
Name of organization / entity
Ardabil Univesity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 3777
Email address
f.amani@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-04-30, 1393/02/10
Expected recruitment end date
2014-07-01, 1393/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectivness of probiotic in the treatment of
gastrointestinal symptoms in patients with
scleroderma
Public title
The Effectivness of probiotic in the treatment of
gastrointestinal symptoms in patients with
scleroderma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with gastrointestinal symptoms moderate to sever
Exclusion criteria: non using drug in exact time; non tolerance for drug side effects; non tended to participate in study
Age
From 18 years old to 57 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Tehran
City
Tehran
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
921128800
Health conditions studied
1
Description of health condition studied
scleroderma
ICD-10 code
M34
ICD-10 code description
Systemic sclerosis
Primary outcomes
1
Description
Improvement in gastrointestinal symptoms
Timepoint
Baseline-two month late
Method of measurement
Score
Secondary outcomes
1
Description
Improvment in reflux condition , emotional and social function
Timepoint
baseline-after two months
Method of measurement
Score
Intervention groups
1
Description
Intervention group: Probiotics use in form of drug pill
Category
Placebo
2
Description
control: placebo similar to main drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Romatology clinic of Imam Khomeini hospital
Full name of responsible person
Shafieh Movassaghi
Street address
Imam Khomeini hospital-Bolvar Keshavarz-Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhonzadeh Basti
Street address
Faculty of medicine,Tehran University of Medical Sciences,Enghelab Avenue-Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Afsaneh Enteshari-Moghaddam
Position
Assistant professor
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
00984533513777
Phone
+98 45 3351 3777
Fax
+98 45 3351 8939
Email
afsanehenteshary@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Afsaneh Enteshari-Moghaddam
Position
Asistant professor
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 3351 3777
Fax
+98 453518939
Email
afsanehenteshary@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University Medical Sciences
Full name of responsible person
Afsaneh Enteshi-Moghaddam
Position
Assistant professor
Other areas of specialty/work
Street address
Ardabil University Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 3351 3777
Fax
+98 45 3351 8939
Email
afsanehenteshary@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)