Abstract
Fecal microbiota transplantation has been proposed as a therapeutic approach for chronic constipation. This randomized, controlled trial aimed to compare the effects of conventional treatment alone (control) with additional treatment with FMT (intervention) in patients with slow-transit constipation (STC). Adults with STC were randomized to receive intervention or control treatment. The control group received education, behavioral strategies, and oral laxatives. The intervention group was additionally provided 6 days of FMT. The primary endpoint was the clinical cure rate (proportion of patients achieving a mean of ≥ three complete spontaneous bowel movements [CSBMs] per week]. Secondary outcomes and safety parameters were assessed throughout the study. Sixty patients were randomized to either conventional treatment alone (n = 30) or FMT (n = 30) through a nasointestinal tube. There were significant differences between the intervention group and control group in the clinical improvement rate (intention-to-treat [ITT]: 53.3% vs. 20.0%, P = 0.009), clinical cure rate (ITT: 36.7% vs. 13.3%, P = 0.04), mean number of CSBMs per week (ITT: 3.2 ± 1.4 vs. 2.1 ± 1.2, P = 0.001), and the Wexner constipation score (ITT: 8.6 ± 1.5 vs. 12.7 ± 2.5, P < 0.00001). Compared with the control group, the intervention group showed better results in the stool consistency score (ITT: 3.9 vs. 2.4, P < 0.00001) and colonic transit time (ITT: 58.5 vs. 73.6 h, P < 0.00001). The intervention group had more treatment-related adverse events than did the control group (50 vs. 4 cases). FMT was significantly more effective (30% higher cure rate) for treatment of STC than conventional treatment. No serious adverse events were observed.
Highlights
Fecal microbiota transplantation (FMT), known as fecal bacteriotherapy or fecal infusion, consists of injection of a liquid filtrate of feces from a healthy donor into the gastrointestinal tract of a recipient individual [1]
Patients who were diagnosed as Slow-transit constipation (STC) and were not responsive to traditional treatments with diet modification [12], enemas, or biofeedback in the previous 6 months were enrolled from November 2015 to February 2016
From November 2015 to February 2016, 85 patients were screened, 30 had conventional treatment alone and 30 recipients were given conventional treatment along with FMT using stools obtained from one universal donor
Summary
Fecal microbiota transplantation (FMT), known as fecal bacteriotherapy or fecal infusion, consists of injection of a liquid filtrate of feces from a healthy donor into the gastrointestinal tract of a recipient individual [1]. FMT has been proposed as a therapeutic approach for functional diseases of the gastrointestinal tract by reestablishment of a wide diversity of intestinal flora. Retrospective case series, and randomized, controlled trials have shown the benefit of FMT in patients with functional bowel disorders, including inflammatory bowel disease and irritable bowel syndrome [2,3,4]. Slow-transit constipation (STC) is defined as an increased colonic transit time (CTT) as measured by radionucleotide techniques or radiopaque markers. Imbalance in composition of stool microbiota has been described in patients with constipation [6,7,8,9]
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