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.