Objective: To determine the effects of probiotic supplementation on some blood parameters and anthropometric indicators of stroke patients admitted to the ICU Inclusion criteria: patients with head injury؛ age between 49-15 years Exclusion criteria: gastric intolerance; GCS = 3-5; blood and its products study population: all patients between 49-15 years of head injury in ICU sample size: 60 intervention: the intervention group was given daily for 2 weeks 2 probiotic supplement intervention time: two weeks consequences initia: recovery of hematological parameters and anthropometric indicator
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060416221N2
Registration date:2014-06-25, 1393/04/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-25, 1393/04/04
Registrant information
Name
Ali Tajabadi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1264 7375
Email address
tajabadia@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Credit and Technology Research Center of Medical Sciences, Sabzevar
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of probiotic supplementation on blood parameters and some anthropometric indicators in head trauma patients admitted to the ICU
Public title
The effect of probiotics on blood parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with head injur؛ age between 49-15 years Exclusion criteria: gastric intolerance; GCS = 3-5; transfusion of blood and its products
Age
From 15 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Sabzevar University of Medical Sciences
Street address
Departement of Sabzevar University of Medical Sciences,Sabzevr,Khorasan Razavi
City
Sabzevar
Postal code
Approval date
2013-12-30, 1392/10/09
Ethics committee reference number
medsab.rec.92.19
Health conditions studied
1
Description of health condition studied
Injuries to the head
ICD-10 code
s00
ICD-10 code description
Superficial injury of head
2
Description of health condition studied
Injuries to the head
ICD-10 code
s06
ICD-10 code description
Intracranial injury
3
Description of health condition studied
Injuries to the head
ICD-10 code
s09
ICD-10 code description
Other and unspecified injuries of head
4
Description of health condition studied
Injuries to the head
ICD-10 code
s02
ICD-10 code description
Fracture of skull and facial bones
Primary outcomes
1
Description
blood parameters
Timepoint
Before Intervention and two weeks after the intervention
Method of measurement
milligrams per deciliter, using laboratory apparatus
2
Description
Anthropometric indicators
Timepoint
Before Intervention and two weeks after the intervention
Method of measurement
Centimeter, usiing meter
Secondary outcomes
1
Description
Gastrointestinal digestion
Timepoint
Before and during the intervention
Method of measurement
Questionnaire in terms of defecation
Intervention groups
1
Description
Two probiotic supplements daily for two weeks of oral in the intervention group
Category
Treatment - Drugs
2
Description
In the control group, no treatment. Before and two weeks after the study were evaluated anthropometric indices and blood parameters.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Training Center - Research - Medical relief Doctor martyr Beheshti
Full name of responsible person
Ali Tajabadi
Street address
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr,Mohammadzadeh
Street address
Sabzevar University of Medical Sciences, Sabzevar, Khorasan razavi
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Ali Tajabadi
Position
Msc
Other areas of specialty/work
Street address
Department of Sabzevar University of Medical Sciences,Sabzevar
City
Sabzevar
Postal code
Phone
+98 57 1444 6070
Fax
Email
alitaj58@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ali Tajabadi
Position
Msc of Nursing
Other areas of specialty/work
Street address
Department of Sabzevar University of Medical Sciences, Sabzevar
City
Sabzevar
Postal code
Phone
+98 57 1444 6070
Fax
Email
alitaj58@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ali Tajabadi
Position
Msc
Other areas of specialty/work
Street address
Deprtment of Sabzevar University of Medical Sciences,Sabzevar
City
Sabzevar
Postal code
Phone
+98 57 1444 6070
Fax
Email
alitaj58@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)