Initially, the purpose and methods of implementation to the patients or their parents will be explained and Written consent to the inclusion criteria of the patients received.
The GCS and some indicators such as waist size (the area around the navel) to compare the amount of flatulence in the beginning of the study And frequency of bowel movements (constipation at the beginning and end of the study was to compare the rate) in these patients are checked on arrival.Then based on the method used to assign patients randomly divided into two groups of 35.In addition to the daily diet of the test group 2 probiotic supplements containing Lactobacillus Zhry lactate fermentation biotech company, Bifidobacterium, Streptococcus and Fructose Oligosaccharides are 100 mg; Gavage every 12 hours with a solution for a given week And to control the food is just as routine.At the end of the first week back some indicators such as waist circumference and Tdaddfat stools are examined and measured.The end results will be compared with each other group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111119911N1
Registration date:2015-01-06, 1393/10/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-06, 1393/10/16
Registrant information
Name
Sara Jahangiri
Name of organization / entity
Sabzevar University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 51 3604 6516
Email address
sarajahangiri448@yahoo.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Of Probiotic Supplementation On Some Digestive Problems, Stroke Patients
Public title
Effect Of Probiotic Supplementation On Constipation and Bloating Stroke Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 80-30; Patients with gastrointestinal problems (constipation and abdominal distension); No obvious bleeding in the upper gastrointestinal tract; Absence of associated diseases that cause constipation, such as diabetes or hypothyroidism; Total parenteral nutrition patients who do not; Patients with GCS (5-15 have;Patients who have the same die; Hydration in patients who have identical conditions; Not receiving medications that cause constipation; Patients who do not exercise and your daily activities to help others do the work in terms of a level; Stroke patients admitted to the ICU, Taleghani Hospital, Mashhad.
Exclusion criteria:The use of probiotics in the following refusal by the patient's physician to the patient; Parents patient's refusal to continue using probiotic supplements; Patients who do not tolerate gavage; Patients with systolic blood pressure lower than 100 millimeters of mercury; The patient died during the study.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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 and Health Services
Street address
Building number two, Vice Chancellor for Education, University of Sabzevar
City
Sabzevar
Postal code
9613873136
Approval date
2014-07-05, 1393/04/14
Ethics committee reference number
medsab.Rec.93.15
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Abdominal circumference
Timepoint
A week before the intervention and after the intervention began.
Method of measurement
Using a tape measure in centimeter.
2
Description
The frequency of bowel movements
Timepoint
A week before the intervention and after the intervention began.
Method of measurement
Based on the registration number of daily excretion in patient chart
Secondary outcomes
1
Description
Side Effect
Timepoint
During the intervention and a week after the intervention
Method of measurement
Observation and scrutiny of the patient's general condition
Intervention groups
1
Description
The control group was routinely given food only / no action
Category
Treatment - Drugs
2
Description
The intervention group consumed (lactate Zhry Capsules, 500 mg, twice a day after meal for a week)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital, Mashhad
Full name of responsible person
Sara Jahangiri
Street address
Taleghani, Tee Ferdowsi Asian Highway, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Musa Al-Reza Taday'oun far
Street address
Building number two, Vice Chancellor for Education, Sabzevar University of Medical Sciences and Health Services
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 and Health Services
Full name of responsible person
Sara Jahangiri
Position
Nursing Graduate Student Sabzevar University of Medical Sciences and Health Services
Other areas of specialty/work
Street address
Building number two, Vice Chancellor for Education, Sabzevar University of Medical Sciences and Health Services
City
Sabzevar
Postal code
9613873136
Phone
+98 51 4444 6070
Fax
+98 51 4444 5648
Email
Sarajahangiri448@yahoo.com
Web page address
www.medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences and Health Services
Full name of responsible person
Sara Jahangiri
Position
Nursing Graduate Student sabzevar University of Medical Sciences and Health Services
Other areas of specialty/work
Street address
Building number two, Vice Chancellor for Education, Sabzevar University of Medical Sciences and Health Services
City
Sabzevar
Postal code
9613873136
Phone
+98 51 4444 6070
Fax
+98 51 4444 5648
Email
sarajahangiri4482yahoo.com
Web page address
www.medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences and Health Services
Full name of responsible person
Sara Jahangiri
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Building number twoVic,vice Chancellor for Education, Sabzevar University of Medical Sciences and Health Services
City
Sabzevar
Postal code
9613873136
Phone
+98 51 4444 6070
Fax
+98 985144445648
Email
Sarajahangiri448@yahoo.com
Web page address
www.medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)