Two-year combination antibiotic therapy with clarithromycin, rifabutin, and clofazimine for Crohn's disease

Background & Aims: Mycobacterium avium subspecies paratuberculosis has been proposed as a cause of Crohn’s disease. We report a prospective, parallel, placebo-controlled, double-blind, randomized trial of 2 years of clarithromycin, rifabutin, and clofazimine in active Crohn’s disease, with a further year of follow-up. Methods: Two hundred thirteen patients were randomized to clarithromycin 750 mg/day, rifabutin 450 mg/day, clofazimine 50 mg/day or placebo, in addition to a 16-week tapering course of prednisolone. Those in remission (Crohn’s Disease Activity Index ≤150) at week 16 continued their study medications in the maintenance phase of the trial. Primary end points were the proportion of patients experiencing at least 1 relapse at 12, 24, and 36 months. Results: At week 16, there were significantly more subjects in remission in the antibiotic arm (66%) than the placebo arm (50%; P = .02). Of 122 subjects entering the maintenance phase, 39% taking antibiotics experienced at least 1 relapse between weeks 16 and 52, compared with 56% taking placebo (P = .054). At week 104, the figures were 26% and 43%, respectively (P = .14). During the following year, 59% of the antibiotic group and 50% of the placebo group relapsed (P = .54). Conclusions: Using combination antibiotic therapy with clarithromycin, rifabutin, and clofazimine for up to 2 years, we did not find evidence of a sustained benefit. This finding does not support a significant role for Mycobacterium avium subspecies paratuberculosis in the pathogenesis of Crohn’s disease in the majority of patients. Short-term improvement was seen when this combination was added to corticosteroids, most likely because of nonspecific antibacterial effects.

Fluoxetine for maintenance of remission and to improve quality of life in patients with Crohn's disease: a pilot randomized placebo-controlled trial.

BACKGROUND AND AIMS: Previous studies have shown that antidepressants reduce inflammation in animal models of colitis. The present trial aimed to examine whether fluoxetine added to standard therapy for Crohn's disease [CD] maintained remission, improved quality of life [QoL] and/or mental health in people with CD as compared to placebo. METHODS: A parallel randomized double-blind placebo controlled trial was conducted. Participants with clinically established CD, with quiescent or only mild disease, were randomly assigned to receive either fluoxetine 20 mg daily or placebo, and followed for 12 months. Participants provided blood and stool samples and completed mental health and QoL questionnaires. Immune functions were assessed by stimulated cytokine secretion [CD3/CD28 stimulation] and flow cytometry for cell type. Linear mixed-effects models were used to compare groups. RESULTS: Of the 26 participants, 14 were randomized to receive fluoxetine and 12 to placebo. Overall, 14 [54%] participants were male. The mean age was 37.4 [SD=13.2] years. Fluoxetine had no effect on inflammatory bowel disease activity measured using either the Crohn's Disease Activity Index [F(3, 27.5)=0.064, p=0.978] or faecal calprotectin [F(3, 32.5)=1.08, p=0.371], but did have modest effects on immune function. There was no effect of fluoxetine on physical, psychological, social or environmental QoL, anxiety or depressive symptoms as compared to placebo [all p>0.05]. CONCLUSIONS: In this small pilot clinical trial, fluoxetine was not superior to placebo in maintaining remission or improving QoL. [ID: ACTRN12612001067864.].

What do participants of the Crohn's and Colitis UK (CCUK) Annual York Walk think of their Inflammatory bowel disease care? A short report on a survey

There has been a growing interest in a patient-centered model of care in inflammatory bowel disease; however, no relevant study using a mixed methodology has been conducted to date. Thus, our multidisciplinary group aimed to explore the issue of patient involvement in care among the inflammatory bowel disease community. A mixed-methods anonymous survey was conducted during the Crohn's and Colitis UK annual event. Summary statistics were used to describe the sample, and a simple thematic analysis identified key themes in qualitative responses. There were 64 survey respondents, representing 73% of the total family/friend groups participating (N = 87). Overall, 75% of respondents answered that they had the opportunity to discuss their care with their inflammatory bowel disease practitioner and 81% felt their opinions were taken on board and valued. A clear majority (84%) had at some point been treated by a gastroenterologist. In contrast, less than half (44%) had the opportunity for a dietician consultation and only 28% had the opportunity for a psychologist/counselor consultation. Although satisfaction with inflammatory bowel disease care was high, access to specialty services was concerning. Efforts should be made to provide access to mental health practitioners for those with clinically significant anxiety and/or depression.