Clinical Question: In patients with...

Clinical Question: In patients with ulcerative colitis popularly in remission, is the probiotic Escherichia coli Nissle 1917 as effective as standard treatment to obviate relapse?

Setting: Outpatient (any)

subject of attention Design: Randomized controlled trial (double-blinded)

Allocation: Uncertain

Synopsis: Probiotics are live, nonpathogenic microorganisms used to alter the microbial balance in the intestinal tract. Although most numerous probiotics are gram-positive species (eg Lactobacillus species), E coli Nissle 1917 is a gram-negative probiotic of a different strain than toxic E coli that may work by means of causing an immune response or preventing invasion of other bacteria.

In this trial, the investigators chronicleed 327 patients with ulcerative colitis in remission who had a history of at least sum of two units acute attacks. Patients were assigned to receive E coli Nissle 1917 probiotic in a dosage of 200 mg one time daily or controlled-release mesalamine (called mesalazine everywhere moreover in the United States) three times daily for 12 month The patients were examined formerly a month for three month then each three months for the remainder of the study

The investigators incorrectly inserted or failed to follow up with 32 percent of the patients. Dropout were common; on the end of the meditation 50 percent of patients receiving E coli Nissle 1917 and 43 percent of patients receiving mesalamine had discontinued therapy because of various moot points or protocol violations. The authors did not mention whether additional therapy could be used or to what degree acute relapse was managed, although they prohibited patients from using antibiotics, sulfonamides, or steroids at entrance to the study.

The main issue was the number of patients experiencing a relapse during the 12 month of the investigation as measured by an undescribed clinical activity index. In patients who maintained therapy (per-protocol analysis), 364 percent of the patients in the E coli Nissle 1917 assign places to relapsed compared with 33.9 percent of patients receiving mesalamine. Relapse rates were similar between the collections when using intention-to-treat analysis (451 versus 370 percent) Discontinuation rates because of adverse efficiencys were similar in the pair groups. The study had a power of 20 percent to find at least a 20 percent difference (not a 20 percentage-point difference) in the rate of relapse, if single in kind exists.

Bottom Line: Treating ulcerative colitis with the probiotic E coli Nissle 1917 is as effective as prophylactic mesalamine in the prevention of relapse. No commercially available harvests containing this nonpathogenic bacteria were located, and the strain (Nissle 1917) is crucial. (Level of Evidence: 1b-)

meditation Reference: Kruis W, et al. Maintaining remission of ulcerative colitis with the probiotic Escherichia coil Nissle 1917 is as effective as with standard mesalazine. disembowel November 2004;53:1617-23.

Used with permission from Shaughnessy AF. Probiotic useful for ulcerative colitis. Accessed online March 1 2005 at: http://wwwlnfo POE Mscom

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