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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
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BMC Gastroenterology

ISSN: 1471-230X

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