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OpenTrials
Completed

NCT Number: NCT04297501

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years old;
  • Documented HIV infection;
  • No history of gastrointestinal diseases;
  • Good adherence and promise to follow-up;
  • Ability to provide informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

Antiretroviral therapy

Drug

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

Primary outcomes

  1. Gut bacterial community diversity and composition

    Time frame: Change from baseline to 1 year after antiretroviral therapy

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

Secondary outcomes

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

    Time frame: Change from baseline to 1 year after antiretroviral therapy

    CD4+ and CD8+ T cells are analyzed by flow cytometry

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

    Time frame: Change from baseline to 1 year after antiretroviral therapy

    CD38+HLA-DR+, CD8+CD28+ T cell subsets are analyzed by flow cytometry

  3. Plasma levels of inflammation and coagulation markers

    Time frame: Change from baseline to 1 year after antiretroviral therapy

    Levels of IL-8, IL-1β, IL-6, CRP, TNF-α and D-dimer

  4. Plasma levels of microbial translocation and monocyte activation markers

    Time frame: Change from baseline to 1 year after antiretroviral therapy

    Levels of I-FABP, LPS, LBP, sCD14, sCD40L, and IDO

  5. Metabolic measurements from blood plasma

    Time frame: Change from baseline to 1 year after antiretroviral therapy

    Levels of vitamin D, glucose and insulin, and lipid profiling

  6. Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures

    Time frame: Change from baseline to 1 year after antiretroviral therapy

    Based on patients' description and intervention-related adverse events

  7. HIV RNA

    Time frame: Change from baseline to 1 year after antiretroviral therapy

    HIV-RNA is detected by Roche assay with the limit of 20 copies/mL

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Effect of 1-year Antiretroviral Treatment on Gut Microbiota Diversity and Composition in Treatment-naïve HIV-infected Chinese Individuals

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2020
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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