Protocol summary

Study aim
Determination of the effect of Familact synbiotic on the outcomes of the patients with community acquired pneumonia (clinical improvement, laboratory and complications)
Design
Patients will be randomly divided into two groups using a random number table. One group will only be given antibiotics and the other group will be given antibiotics together with a capsule of synbiotic (Familact) daily for 10 days. All of the steps will be covered by the patient, physician and evaluators.
Settings and conduct
This prospective double-blind clinical trial study will be performed on the effect of Familact synbiotic in 130 patients over 18 years of age with community-acquired pneumonia admitted in the infectious ward of Vali-e-Asr Hospital in Birjand. Patients will be randomly divided into two groups using a random number table.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years old with community-acquired pneumonia diagnosed by an infectious disease specialist and requiring hospitalization (based on CURB-65 criteria), Patients with the same epidemiological factors (age, gender, and underlying disease) and possible microorganisms, Patients who need one type of treatment and do not need to other treatment such as steroids Exclusion criteria: Patients who have taken antibiotics 48 hours before hospitalization, Patients with immunodeficiency (HIV, receiving immunosuppressive drugs, transplantation, chemotherapy, acute pancreatitis), pregnant and lactating women, Patients who have consumed probiotics, prebiotics and synbiotics in the past month, Patients who have not consented
Intervention groups
Intervention group: Familact capsule (once daily) for 10 days along with antibiotics Control group: Only antibiotics
Main outcome variables
Fever; Respiratory rate; WBC; ESR; CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140623018206N2
Registration date: 2021-07-14, 1400/04/23
Registration timing: prospective

Last update: 2021-07-14, 1400/04/23
Update count: 0
Registration date
2021-07-14, 1400/04/23
Registrant information
Name
Azadeh Ebrahimzadeh
Name of organization / entity
Birjand Universtiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 8671
Email address
a.ebrahimzadeh@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Familact synbiotic on the outcomes of the patients with community acquired pneumonia (clinical improvement, laboratory and complications)
Public title
Evaluation of the effect of Familact synbiotic in treatment of community acquired pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old with community-acquired pneumonia diagnosed by an infectious disease specialist and requiring hospitalization (based on CURB-65 criteria) Patients with the same epidemiological factors (age, gender, and underlying disease) and possible microorganisms Patients who need one type of treatment and do not need to other treatment such as steroids
Exclusion criteria:
Patients who have taken antibiotics 48 hours before hospitalization Patients with immunodeficiency (HIV, receiving immunosuppressive drugs, transplantation, chemotherapy, acute pancreatitis), pregnant and lactating women Patients who have consumed probiotics, prebiotics and synbiotics in the past month Patients who have not consented
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 130
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups using a random number table. In this way, first in Excel software, we create a variable from 1 to 130 (instead of 130, the total sample size). Then we create another variable in another column and generate 65 random numbers one and 65 random numbers two with the randomization command. The numbers of one are intervention group and the numbers of two groups are our placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. The patient and the executor (student) are not aware of the type of treatment each person receives. The tablets are designed in the same shape and in the same shape as the cans. Numbers 1 to 130 are written on dark envelopes and type A or B is placed inside the envelope. Envelopes are such that they will not be visible from the outside. In order, each person who opens the envelope will be opened in order and based on the A or B treatment, a can of A or B tablets will be given to the patient along with an explanation of how to use it.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9718797187
Approval date
2019-11-30, 1398/09/09
Ethics committee reference number
IR.BUMS.REC.1398.264

Health conditions studied

1

Description of health condition studied
community acquired pneumonia
ICD-10 code
J13
ICD-10 code description
Pneumonia due to Streptococcus pneumoniae

Primary outcomes

1

Description
Fever
Timepoint
At first, after 72 hours, and at the end of hospitalization
Method of measurement
Thermometer

2

Description
Respiratory Rate
Timepoint
At first, after 72 hours, and at the end of hospitalization
Method of measurement
Respiratory Rate per minute

3

Description
White blood cells
Timepoint
After 72 hours of hospitalization
Method of measurement
Laboratory test

4

Description
Erythrocyte sedimentation rate
Timepoint
At first, and at the end of hospitalization
Method of measurement
Laboratory test

5

Description
C-Reactive Protein
Timepoint
At first, and at the end of hospitalization
Method of measurement
Laboratory test

Secondary outcomes

1

Description
Complications of pneumonia
Timepoint
At the end of study
Method of measurement
Questionnaire

2

Description
Duration of hospitalization
Timepoint
During the study
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Familact capsule (once daily) for 10 days along with antibiotics. Familact® is a synbiotic compound (probiotic + prebiotic) and it contains high amounts of 9 beneficial and safe bacterial strains along with fructooligosaccharide as a prebiotic. The strains and prebiotics used in this product include the following: Lactobacillus rhamnosus, bifidobacterium lactis, Lactobacillus casei, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium langum, Lactobacillus plantarum, Bifidobacterium bifidum and Streptococcus thermophilus.
Category
Treatment - Drugs

2

Description
Control group: Only antibiotics
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Azadeh Ebrahimzade
Street address
Vali Asr Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9718797187
Phone
+98 56 1444 8671
Email
A.ebrahimzadeh@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazemi
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9718797187
Phone
+98 56 3244 0388
Email
Drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Azadeh Ebrahimzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Birjand University of Medical sciences, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9718797187
Phone
+98 56 1444 8671
Email
a.ebrahimzadeh@bums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Azadeh Ebrahimzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9718797187
Phone
+98 56 1444 7186
Email
a.ebrahimzadeh@bums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Azadeh Ebrahimzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9718797187
Phone
+98 56 1444 7186
Email
a.ebrahimzadeh@bums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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