Table 1 Demographic and baseline clinical characteristics

From: The postbiotic ReFerm® versus standard nutritional support in advanced alcohol-related liver disease (GALA-POSTBIO): a randomized controlled phase 2 trial

 

ReFerm® n = 28

Fresubin® n = 28

Age (IQR), years

62 (56–66)

64 (58–68)

Male sex, n

25 (89%)

22 (79%)

Body mass index ≥ 30 kg/m2, n

14 (50%)

11 (39%)

Type 2 diabetes, n

6 (21%)

3 (11%)

Alcohol consumption

 Abstinent ≥ 1 week prior to inclusion, n

14 (50%)

14 (50%)

 Abstinent ≥ 1 year prior to inclusion, na

7 (25%)

9 (32%)

 Average alcohol intake for active drinkers

36 (14–60)

36 (9–51)

 (IQR), g/day

 Phosphatidylethanol (IQR), µ/La

0.16 (0.00–0.89)

0.20 (0.00–1.28)

Laboratory data

 Alanintransaminase (IQR), U/L

32 (20–50)

28 (22–52)

 Aspartattransaminase (IQR), U/L

43 (26–78)

36 (26–53)

 Gamma-Glutamyltransferase (IQR), U/L

163 (69–411)

132 (66–465)

 Bilirubin, (IQR), umol/L

12 (10–20)

12 (7–18)

 Plateles (SD), 109/L

164 (69)

164 (44)

 INR (SD)

1.15 (0.13)

1.14 (0.17)

 Albumin (SD), g/L

44 (4)

44 (3)

 C-reactive protein (IQR), mg/L

2 (1–4)

2 (1–4)

 MELD-Na (IQR)

9 (8–11)

10 (8–12)

 Child-Pugh class A, n

28 (100%)

28 (100%)

Liver histology

 α-SMA (IQR)b

21.9 (17.7–38.7)

19.7 (11.7–26.8)

 Kleiner fibrosis stage 2/3/4, n

2/6/18

2/9/15

 Lobular inflammation grade 0/1/2/3, n

6/14/6/0

7/17/2/0

 Ballooning grade 0/1/2, n

16/10/0

15/11/0

 Steatosis grade 0/1/2/3, n

13/8/3/2

7/8/9/2

Non-invasive test of liver disease

 TE (IQR), kPa

27.5 (16.5–46.2)

20.2 (13.4–27.0)

 CAP (IQR), dB/m

298.5 (240.0–335.0)

304.5 (262.0–336.0)

 2D-SWE (SD), kPa

23 (13)

22 (12)

 PRO-C3 (SD), ng/mL

27.0 (10.5)

23.0 (7.2)

 Enhanced Liver Fibrosis test (SD)c

10.8 (1.0)

10.5 (0.9)

 Fibrosis-4 score (IQR)c

2.8 (1.8–4.3)

2.7 (1.8–4.4)

  1. Normally distributed data are presented as mean (SD), non-normally distributed data as median (IQR), and categorical data as counts (proportion, %). The sum of percentages may deviate from 100 due to rounding.
  2. INR international normalized ratio, MELD-Na model for end-stage liver disease sodium, α-SMA α smooth muscle actin activation, TE Transient Elastography, CAP Controlled Attenuation Parameter, 2D-SWE two-dimensional shear wave elastography, PRO-C3 fragment of N-terminal type III collagen.
  3. aBased on 49 patients.
  4. bBased on 40 patients.
  5. cBased on 46 patients.