Randomized clinical trials of interventions to modulate the gut microbiome in HIV-1 infected adults


Previous studies have shown that people with a weakened immune system and low levels of T-cells, such as people with HIV infection, have a gut microbiome with reduced microbial diversity and altered microbial composition. Research will therefore study samples from clinical trials in order to decipher the role of antiretroviral therapy (ART) in the gut microbial profile so as to determine whether ART can improve the gut microbiome profile and reconstitute the immune system.


  • To evaluate if ART administered to HIV-1-infected late presenters is associated with improved gut microbial diversity and microbiome composition and function.
  • To evaluate if dolutegravir, an integrase inhibitor with better penetration in gastrointestinal HIV-1 sanctuaries than protease inhibitors, is better than darunavir in improving gut microbial diversity or has a different impact on the gut microbiome composition and function.
  • To identify pre-ART gut microbiome profiles associated with systemic immune reconstitution, systemic inflammation and subsequent gut microbiome changes.
  • To identify clinical and epidemiological predictors of improved gut microbial diversity.
  • To determine the safety, tolerability and acceptability of an intervention in HIV-1-infected subjects based on daily oral prebiotic or synbiotic supplements.
  • To evaluate changes in gut microbial diversity, markers of bacterial translocation and systemic inflammation, and in CD4-T-cell counts during and three months after the intervention.
  • To longitudinally evaluate microbial metabolic and proteomic functional profiles.
  • To evaluate intervention-associated acceptability, quality of life, presence of somatic symptoms and emotional status


IrsiCaixa Karolinska Institutet IDIBAPS