Nancy Toedter Williams

Disclosures

Am J Health Syst Pharm. 2010;67(6):449-458. 

In This Article

Inflammatory Bowel Disease

Inflammatory diseases of the digestive tract include UC, Crohn's disease, and pouchitis. An imbalance of intestinal microflora, specifically high numbers of enteroadhesive and enterohemorrhagic E. coli with UC and reduced levels of bifidobacteria with Crohn's disease, may contribute to the inflammation seen with these diseases. Probiotics may improve the microbial balance of the indigenous flora. Although studies have been conflicting, probiotics seem to be an attractive option in the treatment and prevention of inflammatory bowel disease, providing an appealing alternative to the use of antibiotics.[5,7]

Several studies examining the role of probiotics in UC have suggested that they can induce or maintain disease remission. Three controlled trials compared the probiotic E. coli Nissle 1917 with mesalamine in UC and found that the two therapies were similar in preventing disease relapse, suggesting that the probiotic was equivalent to standard therapy with mesalamine in maintaining remission.[39–41] Two of the studies had notable limitations—diverse patient population[39] and short study duration[40]—but the more recent study was methodologically more sound and confirmed the results of the other two studies.[41] The particular nonpathogenic E. coli probiotic strain used in these three studies has been shown to colonize the intestine and antagonize the pathogenic bacteria seen with UC.[40] Another study investigated the use of S. boulardii in 25 patients who developed a mild-to-moderate clinical flare-up of UC while taking standard maintenance therapy with mesalamine.[42] For various reasons, treatment with corticosteroids was not suitable for these patients. Clinical remission, confirmed endoscopically, was attained in 68% of patients after adding a four-week course of S. boulardii to mesalamine treatment. This study was limited by its small sample size, lack of a control group, and open-label design. Bibiloni et al.[43] noted that a six-week course of VSL#3 was also effective in inducing remission or causing a response in 77% of patients with active mild-to-moderate UC that was unresponsive to conventional therapy. This open-label trial also lacked a control group and involved only 34 patients.

Studies have also investigated the role of probiotics in maintaining remission of Crohn's disease. Guslandi et al.[44] noted that patients with inactive Crohn's disease had a significantly lower clinical relapse rate when receiving a six-month regimen of S. boulardii plus mesalamine versus treatment with mesalamine alone (6.25% versus 37.5%, p = 0.04), suggesting that the probiotic yeast may be beneficial in the maintenance treatment of Crohn's disease. In contrast, Marteau et al.[45] found that a six-month regimen of Lactobacillus johnsonii LA1 was not effective in preventing endoscopic recurrence of Crohn's disease after surgical resection.

Various studies support the use of probiotics, particularly VSL#3, in reducing relapse rates and maintaining remission of pouchitis. Pouchitis is a nonspecific inflammation of the ileal reservoir, which is formed surgically after an ileal pouch–anal anastomosis from a proctocolectomy. It is characterized by increased stool frequency and abdominal cramping.[46–48] Although the etiology of pouchitis is unknown, it may be associated with decreased lactobacilli and bifidobacteria counts as well as increased concentrations of other bacteria.[46] In addition to modifying the endogenous flora, VSL#3 alters the immune response in pouchitis by raising tissue levels of the antiinflammatory cytokine interleukin 10 and reducing tissue levels of tumor necrosis factor, interferon, and matrix metalloproteinase activity.[47,48]

In a randomized, double-blind, placebo-controlled trial involving 40 patients with chronic relapsing pouchitis, Gionchetti et al.[46] found that VSL#3 was significantly more effective than placebo in maintaining remission after nine months. All 20 placebo-treated patients experienced a relapse within four months, while 17 of the 20 patients treated with VSL#3 remained in remission after nine months (p < 0.001). When the probiotic was discontinued at the study's end, these 17 patients also experienced relapse within four months. In addition, fecal concentrations of lactobacilli, bifidobacteria, and S. thermophilus increased significantly from baseline in patients treated with VSL#3 (p < 0.001). Mimura et al.[48] confirmed the efficacy of VSL#3 in maintaining remission in patients with recurrent or refractory pouchitis. In this study, 36 patients whose pouchitis was in remission were randomized to receive VSL#3 or placebo for one year or until relapse. Similar to the previous study, 17 of the 20 patients treated with VSL#3 remained in remission at one year versus only 1 of 16 patients who received placebo (p < 0.0001). In addition to preventing relapses, Gionchetti et al.[47] showed that the probiotic mixture VSL#3 was significantly more effective than placebo in preventing the occurrence of pouchitis (p < 0.05) during the first year after pouch formation in this randomized, double-blind, placebo-controlled study involving 40 patients.

In contrast to those studies with encouraging results using VSL#3 in pouchitis, a three-month trial involving LGG did not show any benefit as primary therapy for ileal pouch inflammation.[49] This trial did not show differences in the mean pouchitis disease activity index scores between treatment with LGG and placebo, and only 40% of patients who received the probiotic had LGG recovered in their fecal flora.

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