Study Highlights Safety, Efficacy of FMT for Patients with HIV

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Results from the systematic review and meta-analysis showed FMT restored the normal microbiome, reduced the risk of gastrointestinal infections, and did not lead to increased adverse events in patients with HIV.

Fecal microbiota transplantation (FMT) is a safe and effective treatment for patients with human immunodeficiency virus (HIV) suffering from alterations in gut microbiota, according to a systematic review and meta-analysis.

“The safety of FMT is still questionable due to the high variation in [gastrointestinal tract] microbiota between the healthy donor and the patient. A limited number of patients participated in studies assessing FMT in immunocompromised patients,” wrote investigators.1

Used mainly to treat persistent Clotridoides difficile infection, FMT involves taking healthy microbiota from donor feces and transferring them to the colon of the recipient, typically performed through a colonoscopy. Although uncommon, infection with another bacterium or virus from the donor stool is a potentially serious side effect.2 This may be dangerous for people with HIV/AIDS because they have damaged immune systems and are susceptible to severe illness.3

Led by Adnan Malik, MD, gastroenterology fellow at Mountain Vista Medical Center, the study assessed the safety and efficacy of FMT as a potential therapy for HIV-related gastrointestinal tract symptoms. Investigators electronically searched PubMed, Scopus, OVID, Web of Science, and Cochrane CENTRAL for clinical studies assessing the use of FMT in patients with HIV and gastrointestinal dysbiosis for inclusion in a meta-analysis.1

Investigators searched databases from inception until November 2021 using the search terms “fecal microbiota transplantation”, “gut microbiome”, “bacteriotherapy”, “Clostridium difficile”, “FMT,” “immunocompromised”, “microbiota”, “immunosuppression”, “HIV”, or “AIDS”. Studies were preliminarily selected based on titles and abstracts. Investigators then reviewed the full content of each selected study.1

To be included in the meta-analysis, studies were required to assess the safety and efficacy of FMT in patients with HIV and gastrointestinal intestinal dysbiosis with or without Clostridium difficile infection, use FMT to restore the disrupted microbiota, measure complications and effectiveness outcomes, and provide sufficient data for statistical analysis. Studies were excluded if they were an essay or review article, involved FMT conducted on patients without HIV, or did not include FMT as an active intervention.1

Investigators’ initial search yielded 486 articles. After title and abstract screening, 19 relevant full-text articles were retrieved and screened for eligibility. Of them, 9 articles were excluded due to lack of fecal transplant or containing patients without HIV. In total, 10 studies involving 310 patients conducted between 2013 and 2021 were reviewed in detail and included in the meta-analysis.1

Upon analysis, results indicated FMT potentially restored the normal microbiome and reduced the risk of gastrointestinal infections in patients with HIV receiving highly active antiretroviral therapy (odds ratio [OR], 0.62; 95% confidence interval [CI], 0.25-0.99), although this finding did not bear statistical significance and was moderately heterogeneous (I2, 60.3%; P = .01). Investigators pointed out the heterogeneity resolved (I2 = 46.5%, P = .00) and the effect became statistically significant (OR, 0.774; 95% CI, 0.62-0.966) following sensitivity analyses excluding a 2016 consecutive series study.1

Further analysis showed adverse events associated with FMT were comparable between HIV and health controls (OR, 0.60; 95% CI, 0.07-4.6), with no statistical difference. Of note, the pooled analysis was substantially heterogeneous (I2, 93.3%; P = .00), and further sensitivity analyses failed to resolve heterogeneity, so investigators used a random-effects model.1

“Current evidence demonstrates that FMT is safe and effective in HIV patients suffering from alterations in gut microbiota. We recommend further multi-centric clinical studies to address the optimal transplant amount and source for FMT,” investigators concluded.1


  1. Malik A, Malik MI. Fecal Microbiota Transplantation in Human Immunodeficiency Virus-Infected Patient Population: A Systematic Review and Meta-Analysis. Gastroenterology Research. doi:
  2. Johns Hopkins Medicine. Fecal Transplant. Treatments, Tests and Therapies. Accessed September 27, 2023.
  3. Centers for Disease Control and Prevention. AIDS and Opportunistic Infections. HIV. Accessed September 27, 2023.