Treatment with the nonpathogenic probiotic yeast Saccharomyces boulardii does not prevent relapse in Crohn’s disease.
The finding – which nevertheless does "not allow the exclusion of the potential therapeutic efficacy of probiotics" – comes from the third study to assess S. boulardii in Crohn’s, wrote Dr. Arnaud Bourreille and colleagues. The results are in the August issue of Clinical Gastroenterology and Hepatology.
In a yearlong, randomized, double-blind, placebo-controlled study, Dr. Bourreille, of the CHU de Nantes, France, and colleagues looked at 159 adult patients enrolled at 32 centers during the acute phase of Crohn’s disease.
Patients were treated for 4 weeks with corticosteroids, budesonide, and/or aminosalicylates, according to the preference of each investigator, until remission. They were then randomized to receive either oral S. boulardii at 1 g daily or a placebo until the end of the study at week 52 or earlier, in the case of relapse, with follow-up conducted every 12 weeks.
Relapse was defined as registering a Crohn’s disease activity index (CDAI) higher than 220 points on follow-up; registering a CDAI between 150 and 220 with an increase of at least 70 points over the baseline value; or requiring a surgical procedure or medical treatment specifically for CD.
The authors found that by 1 year, 80 patients had experienced relapse of Crohn’s: 38 in the S. boulardii group (47.5%) and 42 in the placebo group (52.5%), a nonsignificant difference (P less than .05).
The authors also found that the median time to relapse was not statistically different between groups, at 40.7 weeks for the treatment group (range, 2.6-56.0) and 39.0 weeks for patients taking placebo (range, 0.1-55.0) weeks (P = .78).
Indeed, the only finding that did reach statistical significance was among treatment group and smoking status, where nonsmokers given placebo had more relapses (72.0%) than did those treated with S. boulardii (34.5%; P = .016 for the difference between cohorts).
"However, in smokers and former smokers, the proportion of relapse was not significantly different," added the authors.
Looking at safety, Dr. Bourreille reported that just over half of patients in each group complained of adverse events, including diarrhea, arthralgia, constipation, and abdominal pain.
"One oral fungal infection occurred in one patient treated with S. boulardii," he added. "None of the drug-related AEs was serious."
Compliance was greater than 90% in both the treatment and placebo groups.
Dr. Bourreille conceded that the study was limited by the use of clinical relapse as an endpoint, versus relapse defined by endoscopic findings.
"Clinical recurrence was chosen as the primary endpoint because endoscopic evaluation was not deemed necessary for the surveillance of nonsevere CD," wrote the investigators. "Moreover, at the time the study was designed, the concept of mucosal healing was not considered to be as relevant as it now is."
They added, however, that biological parameters of inflammation "were measured at each visit to ensure that clinical recurrence was associated with objective inflammation."
Dr. Bourreille and several coauthors disclosed ties with multiple pharmaceutical companies, including Biocodex, the maker of S. boulardii. Two coauthors were Biocodex employees.
