Effect of probiotic containing lactobacillus, bifidobacterium and streptococus thermophilus administration on inflammatory, coagulation and oxidative factors in critically ill patients with risk of sepsis
Sepsis is a major problem in critically ill patients which its pathogenesis consists of an impairment in inflammatory, coagulatory and oxidative pathways. Interleukin 6 (IL-6) and procalcitonin (PCT), protein C, total antioxidant capacity (TAC) and serum levels of malondialdehyde (MDA) change in sepsis. Gastrointestinal tract plays a key role in the pathogenesis of sepsis due to destruction of intestinal barrier function and probiotics seem to have beneficial effects in improvement of critically ill patients and reduction of mortality by changing the intestinal flora. Forty critically ill patients receiving enteral nutrition and expected to stay in ICU for at least 7 days without intestinal ischemia or obstruction will be enrolled in the study. They will be randomly assigned to two groups; the intervention group will receive standard treatment plus 2 sachets of probiotic VSL 3 and the placebo group will receive standard treatment plus 2 sachets of placebo for 7 days. 10 cc of blood will be obtained from each patient to evaluate IL-6, PCT, Protein C, TAC and MDA before the study and on days 4 and 7. APACHE II and SOFA score will be calculated for all patients before the study and on days 4 and 7. Also, 28-day mortality will be evaluated for each patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112143320N6
Registration date:2011-12-29, 1390/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-29, 1390/10/08
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic containing lactobacillus, bifidobacterium and streptococus thermophilus administration on inflammatory, coagulation and oxidative factors in critically ill patients with risk of sepsis
Public title
Effect of probiotic on management of critically ill patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) critically ill patients admitted to the surgical ICU with positive SIRS and APACHE II score 15 to 30; 2) receiving enteral nutrition; 3) aging 18-40 years old; 4) expected to stay in ICU for at least 7 days. Exclusion criteria: 1) pregnant and lactating women; 2) patients who cannot tolerate enteral nutrition; 3) unstable hemodynamic; 4) smoking; 5) immune disorders and diabetes mellitus; 6) intestinal obstruction; 7) intestinal ischemia; 8) Patients who are expected to expire in the next 24 hours; 9) HIV-positive; 10) cancer; 11) bedsore; 12) bone marrow, liver or lung transplantation; 13) short bowel syndrome, pancreatitis and kidney or liver failure; 14) receiving Lactulose, mannitol, and glutamine during the study; 15) patients undergoing GI procedures (endoscopy, resection of the bowel and GI surgeries) during the study.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tabriz University of Medical Sciences
Street address
Glgasht street
City
Tabriz
Postal code
Approval date
2011-10-17, 1390/07/25
Ethics committee reference number
9047
Health conditions studied
1
Description of health condition studied
sepsis
ICD-10 code
A41.9
ICD-10 code description
Sepsis, unspecified
Primary outcomes
1
Description
inflammation
Timepoint
days 1, 4, 7
Method of measurement
IL6, PCT
2
Description
Coagulation
Timepoint
days 1, 4, 7
Method of measurement
protein C
3
Description
oxidative stress
Timepoint
days 1, 4, 7
Method of measurement
TAC, MDA
Secondary outcomes
1
Description
mortality
Timepoint
days 1, 4, 7
Method of measurement
being live or dead
Intervention groups
1
Description
2 Sachets of probiotic VSL 3 (containing lactobacillus, bifidobacterium and streptococus species)/day for 7 days
Category
Treatment - Drugs
2
Description
2 sachet of placebo/day for 7 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
ICU- Shohada hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
El-goli street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sarvin Sanaie
Position
MD. PhD student of nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
sarvin.sanaie@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehranghiz Ebrahimi Mamagani
Position
PhD of nutrition. Associated professor
Other areas of specialty/work
Street address
Health and Nutrition faculty, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sarvin Sanaie
Position
MD. PhD of nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
sarvin.sanaie@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)