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Effect of probiotics on pathogenic bacteria in the stomach seminars adult patients undergoing mechanical ventilation in the intensive care unit, a clinical trial

Protocol summary

Summary
Objectives: The aim of this study was to investigate the incidence of ventilator associated pneumonia (VAP) in 140, ICU patients with oral preventive probiotics in the treatment group and the placebo in the control group. Research design: A randomized, double-blind, respective study. Inclusion criteria: age of eighteen years and above, the consent of relatives, patients with tracheal intubation and mechanical ventilation which will be continued to the next 6 days with probability of 95%, starting patients' feeding until 24 hours. Exclusion criteria: pregnancy, weakened immune system due to any reason, suppressor of the immune system, replacement heart valves, vascular grafts, heart trauma, history of rheumatic fever, endocarditis, congenital anomaly of heart, injury of stomach, esophagus, bowel, injury to airway, pancreatitis. Sample Size: 68 patients found eligible based on the inclusion criteria. Interventions: intervention group received probiotics capsule once daily and in the control group, placebo once daily were used. While, Staphylococcus aureus, Pseudomonas and Klebsiella, Acinetobacter were the most common bacteria and the diagnosis of VAP will be based on the culture of sputum culture of BAL. Intervention time: immediately after admission of the qualified patients into the study.

General information

Acronym
Effect of probiotics on pathogenic bacteria in the stomach seminars adult patients undergoing m
IRCT registration information
IRCT registration number: IRCT2012101211091N1
Registration date: 2015-01-28, 1393/11/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-28, 1393/11/08
Registrant information
Name
Majid Yazdani
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
yazdanim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2013-09-01, 1392/06/10
Expected recruitment end date
2015-04-30, 1394/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotics on pathogenic bacteria in the stomach seminars adult patients undergoing mechanical ventilation in the intensive care unit, a clinical trial
Public title
Effect of probiotics on pathogenic bacteria in the stomach seminars adult patients undergoing mechanical ventilation in the intensive care unit, a clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: at least 18 years; the consent of the relatives; unconscious patients with endotracheal tube and under mechanical ventilation; probability of 95% for continuing these circumstances within the next six days; patients within 24 hours of abolished the NPO. Exclusion criteria: pregnancy; weakened immune system due to any reason (HIV, leukemia; lupus; donors receive a suppressed immune systems; heart valve replacement; eclipses, vascular; cardiac trauma; history of rheumatic fever; endocarditis; congenital heart anomalies; injuries of stomach; esophagus or intestine; airway injuries; tracheostomy; pancreatitis.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
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
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
7149713717
Approval date
2013-02-21, 1391/12/03
Ethics committee reference number
ct- 92-6947

Health conditions studied

1

Description of health condition studied
Ventilator Assosiated Pneumonia
ICD-10 code
j15
ICD-10 code description
Bacterial Pneumonia not Elsewhere Classified

Primary outcomes

1

Description
To determine the bacteria in the throat
Timepoint
from arrival to the ICU untill 24 hours
Method of measurement
Colonies Count

Secondary outcomes

empty

Intervention groups

1

Description
Prescribe1 capsule of probiotics (lactocare)which contains 6.18 ×〖10〗^10 coloni of seven probiotics.
Category
Treatment - Drugs

2

Description
1 capsule of placebo
Category
Placebo

3

Description
Take a throat culture in the fourth and sixth day after the first culture
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajae Hospital
Full name of responsible person
Majid Yazdani
Street address
Anesthesiology Office, Namazi Hospital, Zand Street
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Majid Yazdani
Position
Nurse
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 1629 1470
Fax
Email
yazdanimajid70@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Mansoor Masjedi
Position
Anesthesiologist, Intensive Care Fellowship
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 1629 1471
Fax
Email
masjedi@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
English Consultant,Anesthesiology Research Center Staff
Other areas of specialty/work
Street address
Anesthesiology Office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihif@sums.ac.com; masihifarzaneh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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