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Table 1 Clinical trials targeting the microbiota in the treatment for PSC

From: The gut-liver axis in hepatobiliary diseases

Treatment

Drug

Study design

n

Duration

Outcome

Reference

Antibiotic

Metronidazole (< 75 kg 600 mg, > 75 kg 800 mg) or placebo

RCT

80

3 years

ALP -52% (metronidazole) vs -38% (placebo)

Farkkila et al. 2004 [102]

Antibiotic

Vancomycin (125 mg or 250 mg qid) or metronidazole (250 mg or 500 mg tid)

RCT

35

12 weeks

ALP -40% and -46% (vancomycin 125 and 250 mg) vs +13% and -33% (metronidazole 250 and 500 mg)

Tabibian et al. 2013 [103]

Antibiotic

Vancomycin (125 mg qid) or placebo

RCT

29

12 weeks

ALP -53% (vancomycin) vs -8% (placebo)

Rahimpour et al. 2016 [104]

Probiotic

4 lactobacilli, 2 Bifidobacterium

RCT, cross over

14

12 weeks × 2 plus wash-out

No change in liver biochemistry

Vleggaar et al. 2008 [105]

FMT

Faecal sample from a healthy donoradministered during colonoscopy

Open-label pilot study

10

24 weeks observation

No change in liver biochemistry

Gut microbiota profiles were changed with increased diversity, persisting for up to 24 weeks

Allegretti et al. 2019 [106]

  1. FMT Fecal microbiota transplantation, RCT Randomized clinical trial