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.