TABLE 1.
Baseline Demographic Variables for Patients with Ulcerative Colitis and/or Clostridiodes difficile Infection
| UC/CDI (n = 32) | CDI Only (n = 14) | UC Only (n = 11) | P | |
|---|---|---|---|---|
| Age, median (range) | 40.4 (18.1–85.7) | 66.5 (21.2–83.2) | 45.0 (21.5–71.1) | 0.001 |
| Gender, n (%) | ||||
| Female | 11 (34.4) | 7 (50.0) | 5 (45.5) | 0.58 |
| Male | 21 (65.6) | 7 (50.0) | 6 (54.5) | |
| White, n (%) | 29 (90.6) | 13 (92.9) | 10 (90.9) | >0.99 |
| History of Tobacco use, n (%) | 13 (40.6) | 6 (42.9) | 5 (50.0) | 0.93 |
| Extent of Disease Activity in UC, n (%) | ||||
| Proctitis | 0 (0) | NA | 1 (9.1) | 0.30 |
| Left-sided colitis | 5 (15.6) | 3 (27.3) | ||
| Extensive colitis | 1 (3.1) | 0 (0) | ||
| Pan-colitis | 26 (81.2) | 7 (63.6) | ||
| Maintenance Therapy, n (%) | ||||
| 5-ASA | 24 (75.0) | NA | 8 (72.7) | >0.99 |
| Immunomodulators | 15 (46.9) | 5 (45.5) | >0.99 | |
| Biologics | 15 (46.9) | 3 (27.3) | 0.67 | |
| Probiotic use, n (%) | 7 (21.9) | 5 (38.5) | 4 (44.4) | 0.26 |
| Acid suppressive medications, n (%) | 7 (22.6) | 6 (42.9) | 2 (20.0) | 0.67 |
| Prior history of CDI, n (%) | 15 (46.9) | 8 (57.1) | NA | >0.99 |
| Prior use of antibiotics in the past year, n (%) | 25 (80.6) | 12 (85.7) | 3 (30.0) | 0.006 |
| Biochemical parameters, median (range) | ||||
| WBC, K/μL | 7.0 (2.3–21.4) | 10.6 (3.6–18.7) | 9.5 (6.0–15.1) | 0.39 |
| Albumin, g/dL | 3.9 (2.8–5.1) | 3.8 (2.6–4.4) | 4.0 (2.8–4.9) | 0.44 |
| BUN, mg/dL | 13.0 (5.0–21.0) | 12.0 (4.0–57.0) | 10.0 (6.0–25.0) | 0.06 |
| Creatinine, mg/dL | 0.8 (0.6–1.5) | 0.7 (0.5–2.4) | 0.8 (0.7–1.2) | 0.27 |
| Confirmation of CDI, n (%) | ||||
| GDH/EIA positive | 3 (9.4) | 8 (57.1) | NA | 0.001 |
| PCR positive | 29 (90.6) | 6 (42.9) | ||
| Diagnosis of CDI Upon Study Enrollment, n (%) | ||||
| Non-recurrent CDI | 30 (93.8) | 12 (85.7) | NA | 0.60 |
| Recurrent CDIa | 2 (6.2) | 2 (14.3) | ||
| Primary Outcomes | ||||
| CDI Recurrence, n (%) | 14 (43.8) | 7 (50.0) | NA | 0.63 |
| UC Flare, n (%) | 11 (34.4) | NA | NA | NA |
| Steroid Administered for Treatment of UC flare, n (%) | 10 (31.2) | NA | 10 (90.9) | 0.001 |
| Initial Antibiotic Treatment for CDI Recurrence | ||||
| Vancomycin, n (%) | 23 (71.9) | 8 (57.1) | NA | 0.63 |
| Metronidazole, n (%) | 9 (28.1) | 6 (42.9) |
aPatients with diagnosis of CDI upon study entry that occurred within 8 weeks of previous CDI infection were classified as recurrent CDI. These patients could still meet the primary outcomes of recurrent CDI and/or UC flare.
5-ASA, 5-aminosalicylic acid; BUN, blood urea nitrogen; EIA, enzyme immunoassay for the presence of TcdA/TcdB toxin; GDH, glutamate dehydrogenase antigen; PCR, Real-time polymerase chain reaction for the detection of the tcdB gene.