Role of intestinal flora in primary sclerosing cholangitis and its potential therapeutic value

Table 3 Clinical trials related to primary sclerosing cholangitis treatment

Study Phase	Study title	ClinicalTrials.gov identifier	Actual enrollment	Status	Interventions
Phase 1	A Pilot Study of Vancomycin or Metronidazole in Patients with Primary Sclerosing Cholangitis (PSC)	NCT01085760	35 participants	Completed	Drug: vancomycin; Drug: metronidazole
	Minocycline in Primary Sclerosing Cholangitis (PSC)	NCT00630942	16 participants	Completed	Drug: minocycline
	Treating Primary Sclerosing Cholangitis and Biliary Atresia with Vancomycin	NCT02137668	200 participants	Recruiting	Drug: oral vancomycin
	A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis	NCT02464020	8 participants	Completed	Drug: vancomycin
	Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia with Vancomycin (PSC)	NCT01322386	32 participants	Completed	Drug: vancomycin
	Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.	NCT02424175	10 participants	Completed	Biological: Fecal microbiota transplantation
Phase 2	Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis (NUC-3)	NCT01755507	159 participants	Completed	Drug: norursodeoxycholic acid; Drug: placebo
	Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC) (AESOP)	NCT02177136	77 participants	Completed	Drug: OCA; Drug: placebo
	Vancomycin for Primary Sclerosing Cholangitis	NCT03710122	102 participants	Recruiting	Drug: vancomycin; Other: placebo
	Trial of High-dose Urso in Primary Sclerosing Cholangitis	NCT00059202	150 participants	Completed	Drug: ursodeoxycholic acid; Drug: placebo
	Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.	NCT02424175	10 participants	Completed	Biological: fecal microbiota transplantation
Phase 3	Primary Sclerosing Cholangitis with Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects (PSC)	NCT01802073	34 participants	Completed	Drug: oral vancomycin
	Probiotics in Patients with Primary Sclerosing Cholangitis	NCT00161148	12 participants	Unknown1	Drug: probiotics
	Norursodeoxycholic Acid vs Placebo in PSC	NCT03872921	300 participants	Recruiting	Drug: norursodeoxycholic acid
	Vancomycin for Primary Sclerosing Cholangitis	NCT03710122	102 participants	Recruiting	Drug: vancomycin; Other: placebo
	Trial of High-dose Urso in Primary Sclerosing Cholangitis	NCT00059202	150 participants	Completed	Drug: ursodeoxycholic acid; Drug: placebo
Phase 4	Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients	NCT02605213	30 participants	Unknown1	Drug: vancomycin; Drug: placebo

¹Study has passed its completion date and status has not been verified in more than two years.

PSC: Primary sclerosing cholangitis; OCA: Obeticholic Acid; AESOP: Aetiology and Ethnicity in Schizophrenia and Other Psychoses.