VSL#3 Probiotic-Mixture Induces Remission in Patients with Active Ulcerative Colitis

TLDR

Intestinal bacteria are implicated in the initiation and perpetuation of inflammatory bowel disease, while probiotic bacteria may treat and prevent relapse. The study evaluated the safety and efficacy of VSL#3 and its components, and examined biopsy‑associated microbiota in patients with active mild‑to‑moderate ulcerative colitis. Thirty‑four ambulatory patients with active UC received open‑label VSL#3, 3,600 billion bacteria daily in two divided doses for six weeks, and biopsy‑associated bacteria were detected by nucleic‑acid methods with VSL#3 species confirmed by 16S rRNA sequencing. In a six‑week open‑label study of 34 patients, VSL#3 induced remission in 53 % and response in 24 %, yielding a combined remission/response rate of 77 % with no adverse events, and PCR/DGGE confirmed that some probiotic species reached the colonic mucosa.

Abstract

BACKGROUND AND AIMS Intestinal bacteria have been implicated in the initiation and perpetuation of IBD; in contrast, "probiotic bacteria" have properties possibly effective in treating and preventing relapse of IBD. We evaluated the safety and efficacy of VSL#3 and the components, and the composition of the biopsy-associated microbiota in patients with active mild to moderate ulcerative colitis (UC). METHODS Thirty-four ambulatory patients with active UC received open label VSL#3, 3,600 billion bacteria daily in two divided doses for 6 wk. The presence of biopsy-associated bacteria was detected using a nucleic acid-based method and the presence of VSL#3 species confirmed by DNA sequencing of 16S rRNA. RESULTS Thirty-two patients completed 6 wk of VSL#3 treatment and 2 patients did not have the final endoscopic assessment. Intent to treat analysis demonstrated remission (UCDAI ≤ 2) in 53% (n = 18); response (decrease in UCDAI ≥ 3, but final score ≥3) in 24% (n = 8); no response in 9% (n = 3); worsening in 9% (n = 3); and failure to complete the final sigmoidoscopy assessment in 5% (n = 2). There were no biochemical or clinical adverse events related to VSL#3. Two of the components of VSL#3 were detected by PCR/DGGE in biopsies collected from 3 patients in remission. CONCLUSION Treatment of patients with mild to moderate UC, not responding to conventional therapy, with VSL#3 resulted in a combined induction of remission/response rate of 77% with no adverse events. At least some of the bacterial species incorporated in the probiotic product reached the target site in amounts that could be detected.