ABSTRACT
BACKGROUND/AIMS: Four high-quality randomized controlled trials have proven the efficacy of fecal microbiota transplantation (FMT) in active ulcerative colitis (UC). We assessed the efficacy of FMT in a real-world setting involving steroid-dependent patients with UC. METHODS: This was a single-center prospective analysis of data from steroid-dependent patients with UC treated with FMT from September 2015 to September 2017 at the Dayanand Medical College, a tertiary care center in India. Fecal samples from random unrelated donors were administered through colonoscopy at weeks 0, 2, 6, 10, 14, 18, and 22. The primary outcome was achievement of steroid-free clinical remission, and the secondary outcomes were clinical response and endoscopic remission at 24 weeks. Modified intention-to-treat analysis was performed, which included subjects who underwent at least 1 FMT. RESULTS: Of 345 patients with UC treated during the study period, 49 (14.2%) had steroid-dependent UC. Of these 49 patients, 41 underwent FMT: 33 completed 7 sessions over 22 weeks according to the protocol, and 8 discontinued treatment (non-response, 5; lost to follow-up, 2; and fear of adverse effects, 1). At week 24, steroid-free clinical remission was achieved in 19 out of 41 (46.3%) patients, whereas clinical response and endoscopic remission were achieved in 31 out of 41 (75.6%) and 26 out of 41 (63.4%) patients, respectively. All patients with clinical response were able to withdraw steroids. There were no serious adverse events necessitating discontinuation. CONCLUSIONS: A multisession FMT via the colonoscopic route is a promising therapeutic option for patients with steroid-dependent UC, as it can induce clinical remission and aid in steroid withdrawal.
ABSTRACT
Levonorgestrel uterine implants are accepted as a safe and efficacious method of contraception. One of the two major health side effects in a large controlled study of subcutaneous hormonal implants with levonorgestrel was a significant increase in gallbladder disease. Gallbladder hypomotility is recognized as a side effect of the levonorgestrel (progesterone). We recently saw on a Gastroenterology Consult Service, two women under 40-years-of-age who had been transferred from outside hospitals with acute cholecystitis with symptomatic choledocholithiasis. Both required Endoscopic Retrograde Cholangiopancreatography and sphincterotomies in addition to laparoscopic cholecystectomies. Both had hormonal (levonorgestrel-releasing) intrauterine devices in place for contraception. Although one patient had a family history of gallstones, the other did not. Both were nonobese, young women patients. We were struck by the coincidence of seeing two such patients. Few articles in the medical literature detail the clinical risks of gallstone disease in patients with hormonal (levonorgestrel-releasing) intrauterine devices. Our experiences with these two patients led us to believe that patients with risk factors for gallstone disease, such as a positive family history, ethnic predisposition, or obesity, should be warned of possible problems, not only with gallbladder disease, but also of common duct stones.
