Determination of the Effect of Probiotic Tablets on the Number of Oral Candida Colonies in Patients Afflicted with HIV with Immunologic Failure of Patients Referring to West Tehran Health Center
Design
In This Study, 30 HIV-positive People, who despite the Success of a Virological Treatment with Immunological Failure, are eligible for Inclusion in a Study That is under the Supervision of Tehran Health Center in Tehran. Participants are Unrandomly divided into Intervention and Control Groups, Each assigned a Code.
Settings and conduct
This Research Was Unrandomized By Allocating Patients To Two Groups Of Odd And Even Based On The Case Number. All Patients With Definite HIV Diagnosis Who Referred To The West Health Center For Treatment And Despite The Virologic Success Of The Poor Immune System, One Ml Of Oral Saliva Was Taken From Each Person And Transferred To The Microbiology Department Of Shahid Beheshti University In The Standard Environment. In Saboro Dextrose Agar, The Number Of Candidate Colony Was Determined In Terms Of CFU.Ml. Patients Were Unrandomly Divided Into Two Groups Of Intervention And Control The Intervention Group Received Probiotic Pill Daily 2 Tablets For 1 Month And Anti-Retroviral Therapy And Contorol Group Just Anti-Retroviral Therapy
Participants/Inclusion and exclusion criteria
HIV positive People with Immunological Failure who have not been using Antibiotics since 1 Month Prior to the Sampling and Duration of the Study, have not been Using Probiotic Products, and have Collaborated and have a Positive Salivary Candidate Patients who do not have Conditions are not Included in the Study
Intervention groups
The Intervention Group is the Patients who receives ART and Probiotic Pill and for Control Group is ART
Main outcome variables
Reduced Oral Candidia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170618034619N2
Registration date:2017-12-11, 1396/09/20
Registration timing:retrospective
Last update:2017-12-11, 1396/09/20
Update count:0
Registration date
2017-12-11, 1396/09/20
Registrant information
Name
Tarane Farrokhnia
Name of organization / entity
Azad Islamc University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
t_farrokhnia@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Probiotic Pill on Oral Candida in HIV Positive Patients with Immunologic Failure
Public title
The Effect of Probiotic Pill on Oral Mushroom in HIV-positive Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
HIV positive People who have an Immunological Failure
HIV positive People who have a Positive Salivary Candidate
Exclusion criteria:
HIV positive People with an Immunologic Failure that take Antibiotics
HIV positive people with an Immunologic failure who have taken an Anti-fungal Drug
HIV-positive people with an Immunologic Failure that has consumed Probiotic Products
HIV positive people with an Immunologic Failure who are not Cooperatives
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
13
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Azad University of Dentistry
Street address
No.9, Ninth Neyestan Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2016-11-26, 1395/09/06
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,8
Health conditions studied
1
Description of health condition studied
Oral Candida
ICD-10 code
Candidiasi
ICD-10 code description
B37
Primary outcomes
1
Description
Candida Colony Count
Timepoint
At the Beginning of the Study (before the Intervention) and 1 Month after taking the Tablet
Method of measurement
CFU with Microbiological laboratory Methods
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Probiotics / 10,000,000,000 colonies per ml / 2 times a day for 1 month and Anti-Retroviral Therapy
Category
Treatment - Drugs
2
Description
Control group: Anti-Retroviral Therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran West Health Center
Full name of responsible person
Saeed Kalantari
Street address
Tehran West Health Center, Dastgheib St., Ostad Moein Ave.,
City
Tehran
Province
Tehran
Postal code
144961453
Phone
+98 21 6600 6037
Email
Dr.saeed.kalantari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeed Kalantari
Street address
Tehran, Hemmat Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6600 6037
Email
Dr.saeed.kalantari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Tarane Farrokhnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9, Ninth Neyestan Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2276 3459
Email
t_farrokhnia@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran West Health Center
Full name of responsible person
Saeed Kalantari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Tehran West Health Center, Dastgheib St., Ostad Moein Ave.,
City
Tehran
Province
Tehran
Postal code
144961453
Phone
+98 21 6600 6037
Email
Dr.saeed.kalantari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran West Health Center
Full name of responsible person
Saeed Kalantari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Tehran West Health Center, Dastgheib St., Ostad Moein Ave.,
City
Tehran
Province
Tehran
Postal code
144961453
Phone
+98 21 6600 6037
Email
Dr.saeed.kalantari@gmail.com
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