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Comparative study of improvement quality of life before and after lactulose and probiotic in cirrhotic patient

Protocol summary

Study aim
The aim of this study was to evaluate the effects of lactulose and probiotics on the quality of life in cirrhotic patients.
Design
The present study is a clinical trial of phase 3, randomized, double-blind, and parallel, which will be performed on 80 patients with cirrhosis. Patients are randomly divided into two groups.
Settings and conduct
The Quality of Life Questionnaire for Chronic Hepatic Patients (CLDQ), which is based on the patient's symptoms and feelings from 1 to 7, as well as demographic information, will be obtained from the patients. this study will be conducted in the gastroenterology clinic, imam hospital, Ahvaz. Patients are randomized to receive lactulose alone and probiotic lactulose in a group of 40.
Participants/Inclusion and exclusion criteria
patients with cirrhosis for any reason, age above 18. exclusion criteria: History of other chronic diseases other than cirrhosis, History of chronic psychosomatic illness, moderate to severe encephalopathy, brain damage, active infection, active bleeding, acute renal failure, continuous use of occipital benzodiazepines, patient dissatisfaction and probiotic contraindications, such as the use of suppressive drugs or acute and severe infections.
Intervention groups
Patients with cirrhosis are randomly divided into two groups of 40 lactulose alone and probiotic plus lactulose.
Main outcome variables
Quality of life in patients with cirrhosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190306042944N1
Registration date: 2019-04-14, 1398/01/25
Registration timing: registered_while_recruiting

Last update: 2019-04-14, 1398/01/25
Update count: 0
Registration date
2019-04-14, 1398/01/25
Registrant information
Name
Damoon Dehnavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 3542
Email address
dr.damoon@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of improvement quality of life before and after lactulose and probiotic in cirrhotic patient
Public title
effect of probiotic in cirrhosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
cirrhosis with any reasons Age above 18
Exclusion criteria:
Chronic physical or sychiatric illness Encephalopathy Active infection Addiction Intake immunosuppressive drugs Patient Dissatisfaction
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be done by a simple method. The unit of randomization is the individual. Using a random number table, a number is considered for each patient, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the patient should be kept blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Science
Street address
Research Deputy of Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.AJUMS.REC.1397.881

Health conditions studied

1

Description of health condition studied
Cirrhosis
ICD-10 code
K74
ICD-10 code description
Fibrosis and cirrhosis of liver

Primary outcomes

1

Description
quality of life in cirrhosis patients
Timepoint
At the beginning of the study and 3 months later (end of the study)
Method of measurement
According to the quality of life questionnaire for chronic liver patients (CLDQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Lactulose plus probiotics
Category
Treatment - Drugs

2

Description
Intervention group: Lactulose
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology clinic of Ahvaz Imam Khomeini Hospital
Full name of responsible person
Eskandar Hajiani
Street address
Azadegan Blvd. Imam khomeini hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3221 6104
Fax
+98 61 3221 6104
Email
dr.damoon@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad badavi
Street address
Golestan Blvd., Jundishapur University of Medical Sciences, Ahvaz, Deputy of Research and Technology Development
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 7570
Fax
+98 61 3336 1544
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Damoon Dehnavi
Position
Student of specialty
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Azadegan Ave. Imam khomeini Hospiatl
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3321 4578
Email
dr.damoon@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Damoon Dehnavi
Position
Student of specialty
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Azadegan Blvd. Imam Khomeini hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3321 4578
Email
dr.damoon@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Damoon Dehnavi
Position
Student of specialty
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Azadegan Ave. Imam khomeini Hospiatl
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3321 4578
Email
dr.damoon@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
If the decision is to publicate the data, after the unidentified individuals all data will be publicated.
When the data will become available and for how long
The access period will be 6 months after the publication of the results.
To whom data/document is available
Researchers working in academic and industrial institutions can apply to get data.
Under which criteria data/document could be used
To cite. Referring to reference or researcher's permission
From where data/document is obtainable
Dr. Damoon Dehnavi dr.damoon@yahoo.com
What processes are involved for a request to access data/document
Access to articles related to this research Send an email to the responsible author
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