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Table 4 Changes in clinical, endoscopic, and histologic evidence of disease by group

From: Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study

Variable Group   Screen or procedure 12 week [12 wk]–[Bl] P value*
CRP Active #(%) > 0 2 (33%) 4 (67%) 2 (33%) 0.16
  Placebo #(%) > 0 2 (40%) 3 (60%) 1 (20%) 0.32
  Active–Placebo     1.00
Fecal calprotectin Active Mean (SD) 573 (659) 298 (428)  − 275 (246) 0.07
  Placebo Mean (SD) 413 (309) 369 (309)  − 44 (90) 0.34
  Active–Placebo     − 231 (185) 0.08
Fecal lactoferrin Active #(%) positive 7 (100%) 4 (67%) 0 (0%)
  Placebo #(%) positive 6 (75%) 5 (100%) 0 (0%)
  Active–Placebo    
Endoscopic UCEIS score Active Mean (SD) 7.0 (1.8) 6.2 (2.3)  − 0.8 (1.7) 0.29
  Placebo Mean (SD) 8.0 (1.4) 7.6 (1.8)  − 0.4 (0.5) 0.18
  Active–Placebo     − 0.4 (1.3) 0.60
Endoscopic Mayo score Active Mean (SD) 1.5 (0.8) 1.5 (0.5) 0 (0.6) 1.00
  Placebo Mean (SD) 2.2 (0.4) 2.2 (0.4) 0 (0)
  Active–Placebo    0 (0.5) 1.00
Mayo symptom score Active Mean (SD) 5.0 (1.5) 3.5 (3.2)  − 1.5 (3.4) 0.33
  Placebo Mean (SD) 4.2 (1.1) 4.0 (1.4)  − 0.2 (1.1) 0.70
  Active–Placebo     − 1.3 (2.6) 0.44
Histology (Geboes Score) Active Mean (SD) 3.4 (1.2) 2.3 (2.2)  − 1.1 (1.4) 0.11
  Placebo Mean (SD) 4.0 (2.1) 3.8 (2.0)  − 0.2 (1.0) 0.63
  Active–Placebo     − 0.9 (1.2) 0.28
IBDQ bowel system Active Mean (SD) 4.2 (0.7) 5.2 (1.4) 1.0 (1.6) 0.19
  Placebo Mean (SD) 4.1 (0.8) 4.8 (1.2) 0.6 (0.7) 0.11
  Active–Placebo    0.3 (1.3) 0.67
IBDQ emotional health Active Mean (SD) 4.4 (0.9) 5.3 (0.8) 0.9 (1.6) 0.23
  Placebo Mean (SD) 4.9 (1.1) 5.3 (1.0) 0.4 (0.4) 0.09
  Active–Placebo    0.5 (1.2) 0.53
IBDQ systemic systems Active Mean (SD) 4.4 (1.2) 4.9 (1.0) 0.5 (2.0) 0.53
  Placebo Mean (SD) 4.2 (1.1) 4.6 (0.9) 0.5 (0.9) 0.31
  Active–Placebo    0.0 (1.6) 0.96
IBDQ social function Active Mean (SD) 5.0 (0.5) 5.7 (1.6) 0.6 (1.3) 0.27
  Placebo Mean (SD) 5.1 (1.2) 5.9 (1.0) 0.8 (0.5) 0.02
  Active–Placebo     − 0.2 (1.0) 0.79
IBDQ total score Active Mean (SD) 142.8 (16.8) 169.0 (34.0) 26.2 (48.4) 0.24
  Placebo Mean (SD) 146.4 (26.1) 163.4 (27.2) 17.0 (14.4) 0.06
  Active–Placebo    9.2 (37.3) 0.69
  1. Calprotectin (mcg/g) and Lactoferrin (pos/neg) were measured in stool
  2. CRP, serum C-reactive Protein (mg/L); Endoscopic UCEIS, Ulcerative Colitis Endoscopic index of Severy; Mayo symptom score includes subject-reported rectal bleeding, stool frequency, and physician global assessment, IBDQ, Inflammatory Bowel Disease Questionairre
  3. *For within-group comparisons, paired t tests were used for continuous variables and McNemar’s chi square test was used for categorical variables. Between-group comparisons were conducted using two-sample t tests for continuous variables and Fisher’s exact test for categorical variables