Protocol summary

Summary
The purpose of the study and design of the study: The effect of probiotic on the increase in the number of CD4 compared to placebo in patients with HIV who are not treated with Highly Active Anti Retroviral Therapy (HAART), Randomized, double blind, placebo controlled, single center, prospective phase 2, Study population and method: Fifty HIV patients referred to the behavioral health counseling center, Imam Khomeini in1395 to 1396 years with the main inclusion criteria : confirm HIV infection by Western blot analysis; lack of criteria for initiating treatment according to national HIV guideline; no use of probiotic supplements in the past 6 months; have a consent to conduct research , and Main exclusion criteria: active addiction; opportunistic infection in the past ; Liver or Kidney failure; active infection and fever; have a cancer and pregnancy or breastfeeding; a history of allergy or sensitivity to the probiotic or lactose intolerance , are randomized to allocate in intervention group with probiotic capsules containing ( Lactobacillus Rhamnosus GR-1 and Lactobacillus Reuteri RC-14) taking every 12 hours and placebo group with placebo capsules taking every 12 hours, for 6 months , The CD4 and the CRP of patients are measured before, 12 weeks and 24 weeks after treatment in two groups, the outcome of the study: use of probiotic in comparison with placebo can increase the number of CD4 (least significant difference based on similar studies in the past is 15 number of CD4) in patients with HIV.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092228308N1
Registration date: 2016-09-22, 1395/07/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-22, 1395/07/01
Registrant information
Name
Ali Asadollahi Amin
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 0856
Email address
emadiham@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Tehran University of Medical Sciences. Zist Takhmir Company.
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic supplementation Lactobacillus Rhamnosus (RC-14) and Lactobacillus Reuteri ( GR-1) on increasing the number of CD4 in HIV patients, A double blind randomized clinical trial with a placebo control.
Public title
The effect of probiotic in HIV patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Confirm HIV infection by Western blot analysis; lack of criteria for initiating treatment according to national HIV guideline; no use of probiotic supplements in the past 6 months ; have a consent to conduct research Exclusion criteria:On Highly Active Anti Retroviral Therapy (HAART) regimens; active addiction; opportunistic infection in the past; Liver or Kidney failure; inflammatory bowel disease and other well known Gastrointestinal pathology; active infection and fever; younger than 18 and older than 65 years; have a cancer, pregnancy and breastfeeding; being dependent on alcohol; a history of allergy or sensitivity to the probiotic or lactose intolerance; use of other supplement drugs, and multivitamins; Use of growth hormone, testosterone or anabolic agent during the last 6 months.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Permuted block randomization

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hospital Ethics Committee Imam Khomeini, Tehran University of Medical Sciences
Street address
End of Keshavarz Blvd., Imam Khomeini Hospital .
City
Tehran
Postal code
Approval date
2016-08-09, 1395/05/19
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.416

Health conditions studied

1

Description of health condition studied
HIV
ICD-10 code
B24
ICD-10 code description
Unspecified human immunodeficiency virus [HIV] disease

Primary outcomes

1

Description
CD4
Timepoint
At baseline ,three months later, and after 6 months.
Method of measurement
Based on the number per microliter by laboratory blood tests

Secondary outcomes

1

Description
CRP
Timepoint
At baseline ,three months later, and after 6 months.
Method of measurement
Based on the number per microliter by laboratory blood tests

2

Description
Side effects
Timepoint
every 4 week after intervention
Method of measurement
Based on side effects checklist

Intervention groups

1

Description
Zist Takhmir Company probiotic capsules containing ( Lactobacillus Rhamnosus GR-1 and Lactobacil lus Reuteri RC-14 10 ^ 9 colony forming units ), one capsule every 12 hours for 24 weeks.
Category
Treatment - Drugs

2

Description
One Placebo capsule every 12 hours for 4 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Behavioral health counseling center, Imam Khomeini.
Full name of responsible person
Mrs. Dr. Siami
Street address
Imam Khomeini Hospital, End of Keshavarz Blvd., Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Tehran University of Medical Sciences
Full name of responsible person
Miss Moamaei
Street address
Tehran University of Medical Sciences Headquarters, Keshavarz Blvd., First of Gods St., Tehran
City
Tehran
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 Tehran University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Zist Takhmir Company
Full name of responsible person
Dr. Mohammadi
Street address
No. 597, Before Heydarkhani Cross, Eastern Farjam St., Resaalat Sq., Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zist Takhmir Company
Proportion provided by this source
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
Tehran University of Medical Science
Full name of responsible person
Dr. Ali Asadollahi Amin
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Unit 1, Floor1, No. 51, Shahid Sadat Ave., Darvazeh Shemiran, Tehran
City
Tehran
Postal code
Phone
+98 21 7752 0856
Fax
Email
amiyaneh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Ali Asadollahi Amin
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Unit 1, Floor1, No. 51,Shahid Sadat Ave., Darvazeh Shemiran, Tehran.
City
Tehran
Postal code
Phone
+98 21 7752 0856
Fax
Email
amiyaneh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Ali Asadollahi Amin
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Unit 1, Floor1, No. 51, Shahid Sadat Ave., Darvazeh Shemiran, Tehran.
City
Tehran
Postal code
Phone
+98 21 7752 0856
Fax
Email
amiyaneh@gmail.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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