Effect of Probiotics (Saccharomyces boulardii) on Microbial Translocation and Inflammation in HIV-Treated Patients: A Double-Blind, Randomized, Placebo-Controlled Trial

Single-center, double-blind, randomized, placebo-controlled pilot trial at Hospital Universitari del Mar in Barcelona, Spain. It enrolled 44 HIV-1-infected adults aged 18 years or older with chronic infection, stable HAART, and undetectable plasma viral load for at least 2 years; participants included both immunoresponders and immunodiscordant patients.

Saccharomyces boulardii was given orally as 2 capsules 3 times daily for 12 weeks, with 6 × 10^7 living bacteria per capsule. The placebo group received matching capsules 2 times daily? Wait no, placebo: 2 capsules 3 times a day; comparator was placebo in a double-blind design.

Saccharomyces boulardii improved inflammatory and microbial translocation markers in virologically suppressed HIV patients. Compared with placebo, the probiotic group showed decreases in LBP and IL-6, and some effects persisted after treatment discontinuation at Week 24 in intention-to-treat analysis. It did not significantly change CD4+/CD8+ cell counts or broader immune parameters, and no adverse events were associated with probiotic use. The authors concluded that the intervention was well tolerated but that longer treatment and larger studies are needed to define optimal dosing and clinical impact.

This was a small single-center pilot study with 22 participants per arm, limiting precision and generalizability. Treatment lasted only 12 weeks, with follow-up to 24 weeks, and the trial did not assess hard clinical outcomes. Several immune and inflammatory endpoints were measured, but not all changed significantly.