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Table. 2.

Characteristics and Outcomes of Clinical Trials on Fecal Microbiota Transplantation for Crohn’s Disease

Study Disease activity/N Donor Dosage Frequency Delivery Post FMT medication F/U Primary endpoint Remission
Cui et al.34 (2015) [HBI ≥7]/ 30 Patientdirected donor 150-200 mL liquid suspension 1 Mid-gut via gastroscope under anesthesia Mesalazine 3 g for 3 months, then reduce doses to 2.5-1.5 g daily 15 months HBI ≤4 76.7%
Vaughn et al.35 (2016) [HBI ≥5]/ 19 Unrelated donor 50 g stool in 250 mL saline 1 Colonoscopy CD-related medication 26 weeks HBI <5 at 4 weeks 53%
Sokol et al.36 (2020) [HBI >4]/ 17 Unrelated donor 50-100 g in 250-350 mL saline 1 Colonoscopy Treated orally with prednisolone →randomized to receive FMT or sham FMT→No additional medication 24 weeks Successful colonization of donor microbiota at 6 weeks 1) None of the patients reached the primary endpoint
2) Steroid-free clinical remission rate at week 10: 87.5% in the FMT vs 44.4% in the sham, p=0.23
Xiang et al.37 (2020) [HBI 6-10 (median IQR 8)]/ 174 Related and unrelated donor NR Median frequency: 3.5 (IQR 2-5) Mid-gut (almost), including endoscopy, nasojejunal tube 1) Multi-FMT: n=10
2) Steroid/immunomodulators/ exclusive enteral feeding: (n=56)
Median: 43 months (IQR 28-59) The rate of improvement in each therapeutic target 20.1%

HBI, Harvey-Bradshaw Index; IQR, Interquartile range; NR, Not reported.

Korean J Gastroenterol 2021;78:31~36 https://doi.org/10.4166/kjg.2021.089
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