Ignite Creation Date:
2024-05-06 @ 2:22 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04297501
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2018-06-08
Brief Title:
Gut Microbiota Changes of HIV Patients Before and After One Year of ART
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Effect of 1-year Antiretroviral Treatment on Gut Microbiota Diversity and Composition in Treatment-naïve HIV-infected Chinese Individuals
Status:
COMPLETED
Status Verified Date:
2018-02
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:
HIV infection leads to destruction of CD4T cells in the gut-associated lymphoid tissue GALT and promotes a decline in mechanical barrier functions of the gut mucosa and the subsequent translocation of microbial products from the gastrointestinal tract to systemic circulation The gut mucosal immune system is not completely restored by cART and the resultant microbial translocation may contribute to chronic inflammation inadequate CD4 T-cell recovery and increased rates of serious non-AIDS events Many studies have revealed strong and characteristic compositional differences in gut microbiota between individuals with HIV infection and seronegative controls So far several probiotic organisms have shown the ability to enhance intestinal epithelial barrier functions reduce inflammation and support effective Th-1 responses Probiotics mainly stimulates polymeric IgA secretion avoid bacterial overgrowth and their translocation and produce a self-limited inflammatory response through development of regulatory T Treg cells by anti-inflammatory cytokine production Therefore we design a prospective randomized double-blind placebo-controlled study to determine whether the use of a probiotic can expand beneficial microbiota that aid in decreasing bacterial translocation and pro-inflammatory cytokine production thereby improving immune functions in HIV-infected subjects Participants in the intervention group will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily while those in the placebo group will take placebo which contains no probiotic but has the same flavor and characteristics as the probiotic product Gut bacterial community diversity and composition immune recovery and activation in peripheral plasma plasma levels of gut damage microbial translocation and inflammation at baseline and after 12 months of receiving intervention will be analyzed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None