Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02146027
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2014-02-18
Brief Title:
Once a Day Use of Lactobacillus Casei Shirota on HIV-infected Patients Infected Patients
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Immunological Effects of Continuous Once a Day Use of Lactobacillus Casei Shirota on HIV-infected Patients on Suppressive Antiretroviral Treatment With Poor CD4 T-cell Recovery
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study HIV-infected patients with poor recovery of CD4 T cells and successful viral control after treatment with antiretroviral therapy will be enrolled to receive once a day Lactobcillus casei Shirota or placebo in a double-blind randomized fashion Immune parameters will be monitored for 12 weeks in both arms
The main outcome is CD4 T cell recovery Secondary outcomes will include NK cells and T cells immune parameters
The main outcome is CD4 T cell recovery Secondary outcomes will include NK cells and T cells immune parameters
Detailed Description:
In this study HIV-infected patients with poor recovery of CD4 T cells and successful viral control after treatment with antiretroviral therapy will be enrolled to receive once a day Lactobcillus casei Shirota or placebo in a double-blind randomized fashion
The main objective is to investigate whether the continuous once a day 12-weeks use of Yakult product containing Lactobacillus casei Shirota could affect immunological parameters in HIV-infected patients on suppressive antiretroviral treatment with poor CD4 T cell recovery A total of 48 volunteers will be followed for 12 week after initiation of daily use of Lactobcillus casei Shirota or placebo randomized in a 11 ratio
We hypothesize that use of the Yakult product containing Lactobacillus casei Shirota after 12 weeks of continuous use will increase the level of CD4 T-cells at least 50 cellsmm³
We also propose to investigate several markers of immune response including T cellular activation and NK cells function and changes in the intestinal microbiota
The main objective is to investigate whether the continuous once a day 12-weeks use of Yakult product containing Lactobacillus casei Shirota could affect immunological parameters in HIV-infected patients on suppressive antiretroviral treatment with poor CD4 T cell recovery A total of 48 volunteers will be followed for 12 week after initiation of daily use of Lactobcillus casei Shirota or placebo randomized in a 11 ratio
We hypothesize that use of the Yakult product containing Lactobacillus casei Shirota after 12 weeks of continuous use will increase the level of CD4 T-cells at least 50 cellsmm³
We also propose to investigate several markers of immune response including T cellular activation and NK cells function and changes in the intestinal microbiota
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None