NCT04297501

Gut Microbiota Changes of HIV Patients Before and After One Year of ART

Completed Last updated 5 March 2020

What this trial tests

trial testing Antiretroviral Therapy in HIV Infections in 50 participants. Completed in 31 December 2019.

Timeline

1 March 2018

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	1 March 2018
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across China

Drugs / interventions tested

• Antiretroviral Therapy — full drug profile →

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 65, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

HIV infection leads to destruction of CD4+T 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut lactate-producing bacteria promote CD4 T cell recovery on Anti-retroviral therapy in HIV-infected patients.
   Lyu W, Meng Q, Xiao J, Li J, et al · · 2021 · cited 8× · PMID 34141131 · DOI 10.1016/j.csbj.2021.05.021
2. Lights and Shadows of Microbiota Modulation and Cardiovascular Risk in HIV Patients.
   Villoslada-Blanco P, Pérez-Matute P, Oteo JA. · · 2021 · cited 4× · PMID 34202210 · DOI 10.3390/ijerph18136837