Can regular treatment with Lactobacillus GG prevent relapse in patients with ulcerative colitis?

Lactobacillus rhamnosus GG (LGG) was as effective as a mesalazine product in preventing recurrence in patients with ulcerative colitis. However, the study was unblinded and a confirmatory study would be helpful. (LOE = 1b-)

Zocco MA, Dal Verme LZ, Cremonini F, et al. Efficacy of Lactobacillus GG in maintaining remission of ulcerative colitis. Aliment Pharmacol Ther 2006;23:1567-1574.  [PMID:16696804]

Randomized controlled trial (nonblinded)

Self-funded or unfunded

Uncertain

Outpatient (specialty)

These Italian researchers enrolled 187 consecutive patients with ulcerative colitis for an average of 8 years into this study of the probiotic LGG. This species has been used successfully to treat traveler's diarrhea and antibiotic-associated diarrhea. The patients were randomly assigned (allocation concealment uncertain) to receive one of the following regimens for 12 months: LGG 18 billion viable bacteria per day in 2 doses; mesalazine 2400 mg daily; or the combination. The primary outcome was the appearance of ulcerative colitis signs or symptoms that required additional treatment. This study did not blind the patients or the investigators, which is a serious limitation because the clinical outcome in this study makes blinding especially important. Relapse occurred in approximately 17% of patients over the course of the study. Using intention-to-treat analysis, the investigators found similar relapse rates across the 3 treatment groups (15%, 20%, and 16%). Similar findings occurred when patients were evaluated by endoscopy for the presence of colitis.