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

NCT04297501 | Completed

• 1 other identifier: CACTGUT18A
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Gut bacterial community diversity and composition

  Microbiota profiling are performed on fecal samples from each subjects, and 8-10 participants receive gastrointestinal endoscope according to their willingness

  Change from baseline to 1 year after antiretroviral therapy

Secondary Outcomes (7)

• Absolute CD4+ T-cell and CD8+ T-cell counts in peripheral plasma

  Change from baseline to 1 year after antiretroviral therapy

• The level of T cell activation and different immunophenotype in peripheral plasma

  Change from baseline to 1 year after antiretroviral therapy

• Plasma levels of inflammation and coagulation markers

  Change from baseline to 1 year after antiretroviral therapy

• Plasma levels of microbial translocation and monocyte activation markers

  Change from baseline to 1 year after antiretroviral therapy

• Metabolic measurements from blood plasma

  Change from baseline to 1 year after antiretroviral therapy

Study Arms (1)

All participants

All enrolled participants in this study

Drug: Antiretroviral Therapy

Interventions

Antiretroviral Therapy DRUG

All participants receive antiretroviral therapy to control virus replication and restore CD4+ T-cell count.

All participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were recruited from the Department of Infectious Diseases, Peking Union Medical College Hospital, Beijing, China. All participants are Chinese and meet eligibility criteria.

You may qualify if:

• years old;
• Documented HIV infection;
• No history of gastrointestinal diseases;
• Good adherence and promise to follow-up;
• Ability to provide informed consent.

You may not qualify if:

• Administration of antibiotics, probiotics, or prebiotics or experience of diarrhea within the previous 3 months;
• Administration of anti-inflammatory drugs, corticosteroids, immunosuppressive drugs, immunomodulator within the previous 3 months;
• Severe organ dysfunction;
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Facal samples were collected and then DNA was retracted, all samples were stored in -80oC.

MeSH Terms

Conditions

HIV Infections

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Wei LYU

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: March 5, 2020
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 5, 2020

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)