Determining and comparing the effect of symbiotic familact 2 plus on ventilator-associated pneumonia (VAP) in patients admitted to the intensive care unit
Design
The randomized, double-blind clinical trial, with the parallel groups, Phase 3 on 80 patients
Settings and conduct
This trial will be performed in Al-Zahra hospital in Isfahan. Patients will be given oral Familact 2 plus in the first group, and a placebo in the second group. The study is double-blind because the patients and the researcher will not be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria include hospitalization in the intensive care unit under mechanical ventilation, and informed consent to participate in the study. Exclusion criteria include pulmonary infection before the starting of mechanical ventilation.
Intervention groups
Intervention group: In this group, oral FamiLact synbiotic (probiotic + prebiotic) (Biology fermentation Company) 2 tablets daily every 12 hours will be prescribed.
Control group In this group, 2 oral placebo drugs will be prescribed every 12 hours.
Main outcome variables
Duration of stay in ICU; Duration of connection to the ventilator; Incidence of pneumonia; Duration of pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N45
Registration date:2021-10-20, 1400/07/28
Registration timing:prospective
Last update:2021-10-20, 1400/07/28
Update count:0
Registration date
2021-10-20, 1400/07/28
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-22, 1401/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of symbiotic familact 2 plus on ventilator-associated pneumonia (VAP) in patients admitted to the intensive care unit
Public title
The effect of symbiotic familact 2 plus on ventilator-associated pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized in the intensive care unit under mechanical ventilation
Satisfaction to participate in the study
Exclusion criteria:
Pulmonary infection before starting mechanical ventilation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 80 eligible patients are randomly selected. For this, the letter A is written on 40 sheets, and the letter B is written on 40 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to observe blindness, the drugs are prepared in the same shape and amount before the intervention and are coded and given to the ICU nurse. They prescribe them without knowing the type of each drug. Therefore, the patient, the patient, the person recording the clinical and baseline information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-11-26, 1399/09/06
Ethics committee reference number
IR.MUI.MED.REC.1399.756
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J18
ICD-10 code description
Pneumonia, unspecified organism
Primary outcomes
1
Description
Incidence of pneumonia
Timepoint
Two weeks after the start of the intervention
Method of measurement
Based on the patient's symptoms and the result of sputum smear test
Secondary outcomes
1
Description
The length of stay in the ICU
Timepoint
Two weeks after the start of the intervention
Method of measurement
Record the number of days
2
Description
Duration of connection to the ventilator
Timepoint
Two weeks after the start of the intervention
Method of measurement
Record the number of days
Intervention groups
1
Description
Intervention group: In this group, oral FamiLact synbiotic (probiotic + prebiotic) (Biology fermentation Company) 2 tablets daily every 12 hours will be prescribed.
Category
Treatment - Drugs
2
Description
Control group: In this group, 2 oral placebo drugs will be prescribed every 12 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Atousa Hakamifard
Street address
Department of Infectious Diseases and Tropical Medicine, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
atousahakamifard@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atousa Hakamifard
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Department of Infectious Diseases and Tropical Medicine, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
atousahakamifard@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atousa Hakamifard
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Department of Infectious Diseases and Tropical Medicine, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
atousahakamifard@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Faranak Kasiri
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Department of Infectious Diseases and Tropical Medicine, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
faranakkasiri9@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD