there has been ongoing speculation that there is a bacterial cause of ulcerative colitis (UC). Fusobacterium varium, in a prior study by the same researchers below, was found in actively inflamed colonic mucosa of patients with UC. (also, in mice, butyric acid, a byproduct of F. varium, causes UC-like lesions). so, this group devised an antibiotic cocktail active against F. varium (tid regimen of amoxacillin 500mg, tetracycline 500mg, and metronidazole 250mg for 2 weeks) and assessed its efficacy both in 30 patients with steroid-refractory and 64 patients with steroid-dependent active UC (see doi:10.1111/apt.12688). primary endpoint was clinical response at 3 months after treatment completion. secondary endpoints were significant clinical and endoscopic score improvement at 12 months. results:
–Japanese multi-center non-randomized study. mean age 40. in steroid-dependent group, 45 males/19 females. pretty even in steroid-refractory group. extensive disease (70% of colon), mostly moderate severity. routine use of UC meds: sulfasalazine, 5-aminosalicylic acid, pred, azathioprine, 6-MP, mesalazine and/or probiotics — though <10% on azathiprine or mercaptorpurine. in steroid-dependent group, the steroid dose was tapered during the study — after week 8 by 5 mg/week until 20 mg dose. then decreased 2.5 mg/week til off.
–19 of 30 (63.3%) steroid-refractory and 47 of 64 (73.4%) of steroid-dependent had clinical resp in 2 weeks
–at 3 months, 60% of steroid-refractory and 56.3% of steroid-dependent achieved clinical remission
–at 12 months, 66.6% of steroid-refractory and 51.6% of steroid-dependent achieved clinical remission
–endoscopic activity scores paralleled the clinical activity scores
–in group with severe disease (16 pts), 80% with clinical response and 55% with clinical remission at 2 weeks, 3 and 12 months.
–in steroid-responsive group, 39 of 64 (60.9%) were able to stop steroids completely and remained in remission for 3 months
–the colectomy rate was 10% in steroid-refractory UC, less than reported rates with infliximab therapy
so, pretty impressive numbers. small study without control group, but cheap and easy treatment. also, Japanese study, so not sure the colonic microbiome is the same as here. but overall this study reminds me of a similar type study in the lancet around 20 years ago, finding that in a small number of patients with severe ITP and found to have H. pylori, H. pylori treatment led to dramatic remission of their ITP. i happened to see someone around that time with ITP and severe ecchymoses, only marginally responsive to high dose prednisione, found to have H pylori antibody, treated for that and had a complete response within a month, and no recurrence since then….. so, these small research studies can be useful.
geoff