Mayo Clinic: Oral Vancomycin for PSC
Last updated October 2024.
There are a number of publications related to the use of oral vancomycin in PSC. As you review the literature, please remember to critically evaluate the strengths and limitations of each publication.
Publications are listed in reverse chronological order within each section. This list is by no means exhaustive, and we have excluded publications about animal studies. Notes are added solely to assist in navigating the list. Readers are encouraged to read the full text to consider the full context of the evidence in the publication. Please see the PSC Partners Statement about the Use of Medications Not Approved by the FDA for PSC.
Randomized Clinical Trials
2016 - S Rahimpour et al. “A Triple Blinded, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis: a Pilot Study.” Journal of gastrointestinal and liver diseases: JGLD vol. 25,4: 457-464. Full text available without paid subscription at doi: 10.15403/jgld.2014.1121.254.rah. Notes: A blinded, randomized, and placebo-controlled 12-week study with 29 adult PSC patients randomized into two groups. Patient symptoms were tracked in addition to biochemistry. Details of trial can be found on clinicaltrials.gov:NCT02605213.
2013 - JH Tabibian et al. “Randomised clinical trial: vancomycin or metronidazole in patients with primary sclerosing cholangitis - a pilot study. ”Alimentary pharmacology & therapeutics vol. 37,6: 604-12. Full text available without paid subscrition at doi: 10.1111/apt.12232Notes: A randomised 12-week study with 35 adult PSC patients, no placebo, 4 groups dosed with high or low doses of antibiotics oral vancomycin or metronidazole. Details of trial can be found on clinicaltrials.gov:NCT01085760.
2013 - JCM Paterson and J F Dillon. “Commentary: vancomycin or metronidazole in patients with primary sclerosing cholangitis?” Alimentary pharmacology & therapeutics vol. 37,9: 915. Full text available without paid subscrition at doi:10.1111/apt.12282 Notes: Commentary on Tabibian et al 2013 article.
Prospective Studies
2023 - Quraishi et al. "Oral vancomycin induces remission in PSC-IBD, which is associated with a reduction in bile salt hydrolase and colonic amine oxidase activity" S124, page 2123, Journal of Hepatology 2023 vol. 78(S1) | S100–S1212. Abstract book can be downloaded here. Trial was registered at clinicaltrials.gov (NCT05376228). Notes: Phase 2a clinical trial, 15 adults, with goal of identifying "key mechanistic pathways associated with induction of treatment response."
2020 - AH Ali et al. “Open-label prospective therapeutic clinical trials: oral vancomycin in children and adults with primary sclerosing cholangitis.” Scandinavian journal of gastroenterology vol. 55,8: 941-950. Abstract and summarized results can be found at doi: 10.1080/00365521.2020.1787501. Trial details can be found at clinicaltrial.gov NCT01802073 and NCT01322386. Notes: Open-label prospective trial of oral vancomycin in 45 children and 14 adults with PSC followed for at least 12 months. Results reported for biochemistry (blood tests), some biopsies, MRCPs and MREs.
2011 - D Pratt et al "An Open Label Pilot Trial of Oral Vancomycin in Primary Sclerosing Cholangitis - Results of the VIP Trial" Gastroenterology, May;140(5). Full text available without subscription at DOI10.1016/S0016-5085(11)63765-7. Notes: Published as meeting abstract. 7 adult PSC-IBD patients completed 52 weeks of oral vancomycin therapy with pre- and post-therapy biopsy and MRCP.
Large Retrospective Study
2024 - A Ricciuto et al. "Oral vancomycin is associated with improved inflammatory bowel disease clinical outcomes in primary sclerosing cholangitis-associated inflammatory bowel disease (PSC-IBD): A matched analysis from the Paediatric PSC Consortium." Alimentary Pharmacology & Therapeutics vol. 59,10: 1236-1247. doi.org/10.1111/apt.17936 Notes: Retrospective matched study of 70 vancomycin-treated and 210 untreated pediatric PSC-IBD patients. Evaluates odds of IBD clinical remission after 1 year of vancomycin.
2021 - MR Deneau et al. “Oral Vancomycin, Ursodeoxycholic Acid, or No Therapy for Pediatric Primary Sclerosing Cholangitis: A Matched Analysis.” Hepatology (Baltimore, Md.) vol. 73,3: 1061-1073. Full text available without subscription at doi:10.1002/hep.31560 Notes: Retrospective, propensity matched analysis of 264 pediatric PSC patients who received UDCA, oral vancomycin, or no treatment. Evaluates surrogate outcomes at 1 year and if transplanted at 5 years.
2021 - DN Assis and C Levy. “Oral Vancomycin or Ursodeoxycholic Acid for Pediatric Primary Sclerosing Cholangitis? The Uncontroversial Need for Randomized Controlled Trials.” Hepatology (Baltimore, Md.) vol. 73,3: 887-889. Full text available without subscription at doi:10.1002/hep.31702 Notes: Commentary on Deneau et al 2021 study.
2021 - KM Johnson et al. "Letter to the Editor: Oral Vancomycin Versus No Therapy for Pediatric Primary Sclerosing Cholangitis" Hepatology (Baltimore, Md.) vol 74,3: 1716-1717. https://doi.org/10.1002/hep.31764 Notes: Notes: Commentary on Deneau et al 2021 study.
Review Articles and Meta Analyses
2019 - A Shah et al. “Effects of Antibiotic Therapy in Primary Sclerosing Cholangitis with and without Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis.” Seminars in liver disease vol. 39,4: 432-441. Full text available without subscription at doi:10.1055/s-0039-1688501 Notes: systematic review and meta-analysis to assess the effect of antibiotic therapy in PSC. 5 studies including 124 PSC patients who received antibiotics were included.
2018 - JL Dammanet al. “Review article: the evidence that vancomycin is a therapeutic option for primary sclerosing cholangitis.” Alimentary pharmacology & therapeutics vol. 47,7: 886-895. Full text available without subscription at doi:10.1111/apt.14540 Notes: 2018 review article summarizing 2 randomized clinical trials, 3 case series, and 2 case reports that together include uncontrolled data from at least 98 patients.2018 - RW Chapman “Editorial: vancomycin - a promising option for the treatment of primary sclerosing cholangitis?” Alimentary Pharmacology & Therapeutics vol. 47,9: 1321-1322. doi:10.1111/apt.14586 Notes: Editorial response to 2018 Damman et al review article.
2017 - F Saffioti et al. “Pharmacological interventions for primary sclerosing cholangitis: an attempted network meta-analysis.” The Cochrane database of systematic reviews, vol. 3,3 CD011343. 28 March, doi:10.1002/14651858.CD011343.pub2 Notes: a network meta‐analysis of 22 trials including the 2016 Rahimpour et al and the 2013 Tabibian et al RCTs that included oral vancomycin therapy.
Case Series and Case Studies
2024 - Sohal, Aalam, and Kris V Kowdley. “Complete Biochemical Remission With Oral Vancomycin in a Patient With Primary Sclerosing Cholangitis and High Serum Immunoglobulin G4 Levels.” ACG case reports journal vol. 11,1 e01256. 16 Jan. 2024, doi:10.14309/crj.0000000000001256
2022 - A Shah et al. How frequent are vancomycin-resistant enterococci in patients with primary sclerosing cholangitis and ulcerative colitis treated with oral vancomycin?. Indian J Gastroenterol. https://doi.org/10.1007/s12664-022-01286-9. Notes: Evaluation of incidence of VRE via rectal swab in 7 adult PSC/IBD patients treated with oral vancomycin.
2021 - F Balouch et al "Paediatric Primary Sclerosing Cholangitis-Ulcerative Colitis. Audit of 2 year Outcome with Oral Vancomycin Treatment". Gastroenterology, May;160(6):S-44. Full text available without subscription at doi.org/10.1016/S0016-5085(21)00852-0. Notes: 29 children with PSC and IBD (most failing conventional medical therapy for UC) treated with oral vancomycin. Study evaluates remission of UC over 2-year follow-up.
2021 - SL Britto et al. “Microbiome Responses to Vancomycin Treatment in a Child With Primary Sclerosing Cholangitis and Ulcerative Colitis.” ACG case reports journal vol. 8,5 e00577. 11 May. Full text available without subscription at doi:10.14309/crj.0000000000000577. Notes: Case study of 7-year-old PSC/IBD patient with longitudinal microbiome analysis.
2021 - CW Buness et al. “Successful response of primary sclerosing cholangitis and associated ulcerative colitis to oral vancomycin may depend on brand and personalized dose: report in an adolescent.” Clinical journal of gastroenterology vol. 14,2 : 684-689. Full text available without subscription at doi:10.1007/s12328-020-01296-0. Notes: Case study of adult with PSC/IBD who started oral vancomycin treatment as a teen.
2021 - A Di Giorgio et al. “Use of oral vancomycin in children with autoimmune liver disease: A single centre experience.” World journal of hepatology vol. 13,12:2113 2127 doi:10.4254/wjh.v13.i12.2113 Notes: Retrospective evaluation of response of PSC for 12 pediatric PSC patients taking oral vancomycin after failing standard immunosuppresion at an Italian centre.
2021 - AU Rahman et al. The role of oral vancomycin in inducing remission for biologic-experienced ulcerative colitis with concomitant primary sclerosing cholangitis and liver transplantation. Clin J Gastroenterol 14, 159–164. https://doi.org/10.1007/s12328-020-01272-8 Notes: Case study of an adult post-transplant PSC/IBD patient; reports on UC response to oral vancomycin treatment after failing conventional UC medications.
2019 - A Dao et al. Letter to the Editor: “Oral Vancomycin Induces and Maintains Remission of Ulcerative Colitis in the Subset of Patients With Associated Primary Sclerosing Cholangitis.” Inflammatory bowel diseases vol. 25,7: e90-e91. Letter can be found without subscription at doi:10.1093/ibd/izz027 Notes: Retrospective chart review of response of UC in 8 PSC/UC patients seen at an IBD clinic (at US hospital) who were treated with oral vancomycin. No evaluation of response of PSC to treatment. Follow-up time from 9-36 months.
2019 - LZ Tan et al. “Oral vancomycin induces clinical and mucosal remission of colitis in children with primary sclerosing cholangitis-ulcerative colitis.” Gut vol. 68,8: 1533-1535. doi:10.1136/gutjnl-2018-316599 Notes: Retrospective study of IBD response to oral vancomycin over median 8.1 months on 7 pediatric PSC/IBD patients.
2018 - GP de Chambrun et al. “Oral vancomycin induces sustained deep remission in adult patients with ulcerative colitis and primary sclerosing cholangitis.” European journal of gastroenterology & hepatology vol. 30,10: 1247-1252. doi:10.1097/MEG.0000000000001223 Notes: Case studies of 3 adult PSC/IBD patients taking oral vancomycin.
2017 - P Hey et al. “Efficacy of oral vancomycin in recurrent primary sclerosing cholangitis following liver transplantation.” BMJ case reports vol. 2017 bcr2017221165. 25 Sep., doi:10.1136/bcr-2017-221165 Notes: Adult post-transplant PSC. r-PSC diagnosed 3 years after transplant.
2014 - S Brost et al. "Orale Therapie mit Vancomycin als Therapieoption bei Primär Sklerosierender Cholangitis" Z Gastroenterol 2014; 52 - KG125 DOI: 10.1055/s-0034-1386147 Notes: Adult PSC patient started on oral vancomycin for C-diff infection. Reports on biochemistry and symptoms after starting, stopping, and starting oral vancomycin again.
2013 -DN Abarbanel et al. “Immunomodulatory effect of vancomycin on Treg in pediatric inflammatory bowel disease and primary sclerosing cholangitis.” Journal of clinical immunology vol. 33,2: 397-406. Full text available without subscription at doi:10.1007/s10875-012-9801-1. Notes: Examination of the in vivo immunological changes that occur during oral vancomycin treatment of the 14 children with PSC and IBD in the case series described in Davies et al 2008 .
2013 - YK Davies et al. “Successful treatment of recurrent primary sclerosing cholangitis after orthotopic liver transplantation with oral vancomycin.” Case reports in transplantation vol.: 314292. Full text available without subscription at doi:10.1155/2013/314292. Notes: Case study of one pediatric post-transplant PSC patient who started oral vancomycin after developing recurrent PSC.
2008 - YK Davies et al. “Long-term treatment of primary sclerosing cholangitis in children with oral vancomycin: an immunomodulating antibiotic.” Journal of pediatric gastroenterology and nutrition vol. 47,1: 61-7. Full text available without subscription at doi:10.1097/MPG.0b013e31816fee95 Notes: Case studies of 14 pediatric PSC patients treated with oral vancomycin.
1998 - KL Cox and KM Cox. “Oral vancomycin: treatment of primary sclerosing cholangitis in children with inflammatory bowel disease.” Journal of pediatric gastroenterology and nutrition vol. 27,5: 580-3. Full text available without subscription at doi:10.1097/00005176-199811000-00015. Notes: Case studies of 3 pediatric PSC patients treated with oral vancomycin.
Commentary/Letters to the Editor/etc.
2024 - Shah A, Holtmann G. Editorial: Is it time to include oral vancomycin in therapeutic guidelines for primary sclerosing cholangitis-associated inflammatory bowel disease? Aliment Pharmacol Ther. 2024 May; 59(10):1290-1291. doi: 10.1111/apt.17990. PMID: 38652768. https://pubmed.ncbi.nlm.nih.gov/38652768/
2023 - J Halma et al. The Time is Ripe for a Randomized Controlled Trial of Oral Vancomycin in Primary Sclerosing Cholangitis. Clinical Gastroenterology and Hepatology LETTER TO THE EDITOR| VOLUME 21, ISSUE 10, P2699-2700, SEPTEMBER 2023, https://pubmed.ncbi.nlm.nih.gov/36442726/. Notes: Full text here.