The aim of the study was the evaluation of the effect of probiotic administration of interleukins 6 and 10 levels in poisoned patients admitted to the ICU of Loghman hospital in 1400.
Design
Clinical trial with two intervention groups with parallel groups of double-blind randomized phase 3 on 100 patients. Creating randomization will be done as a simple randomization and by preparing black and white beads of the same shape and size.
Settings and conduct
Patients with poisoning and hospitalized in the special care department of Loqman Hakim hospital in Tehran will be selected and will be divided into two groups receiving probiotics and placebo by simple randomization and through colored beads. Probiotic group, received 2 probiotic capsules daily up to 7 days and the placebo group will receive the same placebo daily for 7 days. The level of interleukins 6 and 10 was checked before treatment and one week later, and the results of these changes and the significance or not of these statistics can be checked and concluded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: poisoned patients admitted to the ICU receiving enteral nutrition and staying in the ICU for at least seven days. Exclusion criteria: patients with enteral feeding intolerance, intestinal obstruction, kidney failure, pancreatitis, short bowel syndrome, a history of chemotherapy.
Intervention groups
Patients with poisoning and hospitalized in ICU are divided into two groups, control group and intervention group, the intervention group received placebo once every 8 hours for 7 days and the control group received two probiotic capsules every 8 hours for 7 days as gavage.
Main outcome variables
IL-6 and IL-10
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210720051946N5
Registration date:2022-10-06, 1401/07/14
Registration timing:prospective
Last update:2022-10-06, 1401/07/14
Update count:0
Registration date
2022-10-06, 1401/07/14
Registrant information
Name
Peyman Erfan Talab Evini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5102 5000
Email address
peyman1346erfan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of probiotic administration of interleukins 6 and 10 levels in poisoned patients admitted to ICU of Loghman hospital in 1400
Public title
Evaluation efficacy of probiotics on some inflammatory factors of ICU cases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with poisoning
Admission to the ICU
Receive enteral nutrition
ICU admission for at least seven days
Exclusion criteria:
Intestinal obstruction
Renal failure
Pancreatitis
Short bowel syndrome
History of chemotherapy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization type will be simple randomization. 100 beads of the same shape and size and with black and white colors will be selected. Then these 100 beads are mixed and thrown into a non-transparent bag. When the patient visits, according to the conditions of entering the study, the researcher will remove a bead from the bag, and if the bead is black, the patient will enter the control group, and if the bead is white, the patient will enter the intervention group. This bead will be stored inside another bag. This will be repeated 100 times.
Blinding (investigator's opinion)
Double blinded
Blinding description
People from the research team who are responsible for the selection and randomization of patients will not be included in the other stages of the research, especially the examination of people in terms of dependent variables. Also after consent form approval, neither patients nor their companions were informed about patients group of control and intervention. Also in control group we will use placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Aarabi Ave, Velenjak, Tehran City
City
Tehran
Province
Tehran
Postal code
1333635445
Approval date
2022-08-15, 1401/05/24
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.299
Health conditions studied
1
Description of health condition studied
Intoxication
ICD-10 code
A05
ICD-10 code description
Other bacterial foodborne intoxications, not elsewhere classified
Primary outcomes
1
Description
IL-6
Timepoint
Before treatment and after complete period of treatment
Method of measurement
kgf kit
2
Description
IL-10
Timepoint
Before treatment and after complete period of treatment
Method of measurement
kgf kit
Secondary outcomes
empty
Intervention groups
1
Description
Control group: For seven days, TDS received placebo
Category
Placebo
2
Description
Intervention group: For seven days TDS received two probiotic capsules as gavage.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Dr Peyman Erfan Talab Evini
Street address
Loghman Hospital kamali st. Kargar st, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
peyman1346erfan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarbi
Street address
No. 2, Shahid Aarabi St.,, Yemen St., Shahid Chamran Highway., Tehran city
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?