Table 1. Baseline Characteristics of the Study Groups.
| Characteristic | Donor Fecal Microbiota Transplantation (n = 38) | Autologous Fecal Microbiota Transplantation (n = 35) |
|---|---|---|
| Sex, No. (%) | ||
| Women | 18 (47) | 15 (43) |
| Men | 20 (53) | 20 (57) |
| Age, median (IQR), y | ||
| At diagnosis | 30.5 (22-48) | 29 (21-39) |
| At randomization | 38.5 (28-52) | 35 (25-46) |
| Duration of disease, median (IQR), y | 4.9 (1.6-9.6) | 5.8 (2.4-11) |
| Left-sided disease only, No. (%)a | 23 (61) | 22 (63) |
| Total Mayo score, mean (SD)b | 7.2 (1.7) | 7.4 (1.9) |
| Medication, No. (%) | ||
| Oral steroids | 8 (21) | 11 (31) |
| Oral 5-ASA | 33 (87) | 24 (69) |
| Topical 5-ASA | 11 (29) | 7 (20) |
| Immunomodulatorc | 14 (37) | 15 (43) |
| Biologicsd | 3 (8) | 4 (11) |
| Inflammatory markers, median (IQR) | ||
| CRP, mg/L | 2.8 (1.3-7.2) | 2.3 (0.8-10) |
| WBC count, /μL | 6200 (5300-7300) | 7900 (6100-8900) |
| Fecal calprotectin, mg/kg | 566.5 (372.5-2687.5) | 774 (221-1768) |
| Diet, mean (SD)e | ||
| Protein, g | 97 (38) | 109 (42) |
| Carbohydrate, g | 230 (70) | 221 (102) |
| Total Fat, g | 76 (33) | 86 (34) |
| Saturated Fat, g | 29 (16) | 32 (15) |
| Sugars, g | 90 (36) | 103 (74) |
| Starch, g | 139 (56) | 115 (54) |
| Fiber, g | 19 (8) | 21 (8) |
| Calcium, mg | 700 (467) | 718 (447) |
| Iron, g | 11.1 (6.5) | 10.8 (4.4) |
| Energy, kJ | 8742 (2574) | 9049 (3111) |
| Sulfate, mg | 1768 (2110) | 2073 (3191) |
Abbreviations: 5-ASA, 5-aminosalicylate; CRP, C-reactive protein; IQR, interquartile range; WBC, white blood cell.
SI conversion factor: To convert CRP to nmol/L, multiply by 9.524.
a
Left-sided disease only defined as disease not extending proximal to the splenic flexure.
b
Total Mayo score is a composite of clinical and endoscopic parameters. It ranges from 0 to 12 (clinical remission ≤2; mild disease, 3-6; moderate disease, 7-10; and severe disease, 11-12).
c
Immunomodulators were either azathioprine or 6-mercaptopurine.
d
Biologics were either infliximab or vedolizumab.
e
Dietary information was acquired via 3-day diet diary conducted prior to patient receiving fecal microbiota transplantation.