Objectives: To assess the effect of a probiotic supplementation versus no treatment on level of salivary TNF-α in patients with type 2 diabetes.
Design: a randomized clinical trial.
Setting and conduct: The eligible patients who will refer to the School of Dentistry during the study period will be enrolled into the trial.
Inclusion criteria: (a) having type 2 diabetes; (b) body mass index equal to or greater than 25.
Exclusion criteria: (a) using insulin, corticosteroids, immunosuppressive drugs, or non-steroidal anti-inflammatory drugs; (b) smoking; (c) thyroid dysfunction; (d) cardiovascular diseases or renal failure; (e) pregnancy or breastfeeding; (f) using any kind of probiotic products in the past two months.
Intervention group: Routine treatment plus Familact capsule 500 mg one a day for 8 weeks
Control group: Routine treatment only.
Primary outcome: Measuring the level of TNF-α using Bendcrmedsystem kit in fourth and eighth weeks after treatment.
Secondary outcome: Nothing.
Randomization: Random assignment of the patients to the intervention and control groups one at a time.
Blinding: without blinding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603029014N93
Registration date:2016-04-03, 1395/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-03, 1395/01/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a probiotic supplementation versus no treatment on level of salivary TNF-α in patients with type 2 diabetes: a randomized clinical trial
Public title
The effect of a probiotic supplementation versus no treatment on level of salivary TNF-α in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) having type 2 diabetes; (b) body mass index equal to or greater than 25.
Exclusion criteria: (a) using insulin, corticosteroids, immunosuppressive drugs, or non-steroidal anti-inflammatory drugs; (b) smoking; (c) thyroid dysfunction; (d) cardiovascular diseases or renal failure; (e) pregnancy or breastfeeding; (f) using any kind of probiotic products in the past two months.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups one at a time.
Blinding: without blinding.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-12-26, 1394/10/05
Ethics committee reference number
IR.UMSHA.REC.1394.404
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Measuring the level of TNF-α
Timepoint
in fourth and eighth weeks after treatment
Method of measurement
using Bendcrmedsystem kit
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Routine treatment plus Familact capsule 500 mg one a day for 8 weeks
Category
Treatment - Drugs
2
Description
Routine treatment only
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Maryam Mardani
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
School of Dentistry
Full name of responsible person
Maryam Mardani
Position
Dentistry Student
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
maryammardani292@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Mohammad Vahedi
Position
Oral and Maxillofacial Specialist
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
vahedi_md@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)