A Triple Blinded, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis: a Pilot Study

Rahimpour, Shahab; Nasiri-Toosi, Mohsen; Khalili, Hossein; Ebrahimi‐Daryani, Nasser; Nouritaromlou, Mohammad Kazem; Azizi, Zahra

doi:10.15403/jgld.2014.1121.254.rah

Cited by 91 publications

(68 citation statements)

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“…Oral vancomycin has been shown to treat both PSC and associated IBD . Vancomycin is a glycopeptide antibiotic active against Gram‐positive bacteria.…”

Section: Discussion Of Trials and Case Reportsmentioning

confidence: 99%

Review article: the evidence that vancomycin is a therapeutic option for primary sclerosing cholangitis

Damman

Rodríguez

Ali

et al. 2018

Aliment Pharmacol Ther

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SummaryBackground and Aims: PSC is an autoimmune biliary inflammatory disorder that is often associated with inflammatory bowel disease (IBD), with 50%-75% of patients with PSC having coexisting IBD, most commonly ulcerative colitis. Currently, no medical therapies have been shown to improve the disease course or slow its progression. However, ongoing research has resulted in a growing interest in the use of antibiotics for treatment of PSC, of which vancomycin is the most studied. In this review, we summarise the current evidence on the use of vancomycin in PSC and comment on future research areas of interest.Methods: A comprehensive PUBMED and EMBASE literature search for articles on vancomycin, PSC, therapeutic options and microbiome was performed.Results: Two randomised clinical trials, three case series and two case reports were included in the study. These include uncontrolled data from at least 98 patients that include promising improvements in biochemistry and imaging. Optimal dosing regimens are unclear. Conclusion:Vancomycin is one of the most studied antibiotics used in the treatment of PSC with promising results. There is not currently sufficient evidence to support treatment recommendations. Further research is needed to establish if vancomycin is a PSC treatment.

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“…Oral vancomycin has been shown to treat both PSC and associated IBD . Vancomycin is a glycopeptide antibiotic active against Gram‐positive bacteria.…”

Section: Discussion Of Trials and Case Reportsmentioning

confidence: 99%

Review article: the evidence that vancomycin is a therapeutic option for primary sclerosing cholangitis

Damman

Rodríguez

Ali

et al. 2018

Aliment Pharmacol Ther

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“…Small randomized controlled trials of both low and high doses of vancomycin for PSC over 12 weeks have shown a decrease in baseline ALP of 18%‐43%, improvement of the MRS and improvement in symptoms including pruritus, fatigue, diarrhoea and anorexia . These results show promise and larger trials over longer periods are needed to assess the efficacy of vancomycin.…”

Section: Novel Therapiesmentioning

confidence: 99%

Novel and emerging therapies for cholestatic liver diseases

Goldstein

Levy

2018

Liver International

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While bile acids are important for both digestion and signalling, hydrophobic bile acids can be harmful, especially when in high concentrations. Mechanisms for the protection of cholangiocytes against bile acid cytotoxicity include negative feedback loops via farnesoid X nuclear receptor (FXR) activation, the bicarbonate umbrella, cholehepatic shunting and anti-inflammatory signalling, among others. By altering or overwhelming these defence mechanisms, cholestatic diseases such as primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) can further progress to biliary cirrhosis, end-stage liver disease and death or liver transplantation. While PBC is currently treated with ursodeoxycholic acid (UDCA) and obeticholic acid (OCA), many fail treatment, and we have yet to find an effective therapy for PSC. Novel therapies under evaluation target nuclear and surface receptors including FXR, transmembrane G-protein-coupled receptor 5 (TGR5), peroxisome proliferator-activated receptor (PPAR) and pregnane X receptor (PXR). Modulation of these receptors leads to altered bile composition, decreased cytotoxicity, decreased inflammation and improved metabolism. This review summarizes our current understanding of the role of bile acids in the pathophysiology of cholestatic liver diseases, presents the rationale for already approved medical therapies and discusses novel pharmacologic therapies under investigation.

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“…Tabibian et al randomized thirty-five patients with PSC into four groups: vancomycin 125 mg or 250 mg four times per day and metronidazole 250 mg or 500 mg three times per day; all groups improved but the vancomycin groups showed the greatest improvement [10]. In a triple-blinded, randomized, placebo-controlled trial of twenty-nine patients, of which eighteen were treated with oral vancomycin 125 mg four times daily for twelve weeks, Rahimpour et al found that vancomycin significantly reduced the PSC Mayo risk scores as well as the levels of alkaline phosphatase [11]. Dao et al described improvements in both ulcerative colitis and PSC in eight patients, five of whom had undergone liver transplant, when treated with oral vancomycin 125 mg four times daily for 6-8 weeks, after which the dose was tapered but not discontinued; all patients maintained endoscopic response/remission [12].…”

Section: Discussionmentioning

confidence: 99%

“…Several investigators have posited that vancomycin's capacity to treat PSC is due, in part, to its action as an immunomodulator. [18] While the impact of vancomycin on patients with PSC leads to decreased inflammatory parameters [11,18], vancomycin could also mitigate inflammation if it is treating the microbial trigger of an autoimmune reaction. Howden et al demonstrated that the development of low-level vancomycin resistance in methicillin resistant Staphylococcus aureus is associated with changes in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) and decreased tumor necrosis factor-alpha (TNF-α) [60]; however, this decrease in the host pro-inflammatory response to infection is not evidence that vancomycin is an immune modulator.…”

Section: Discussionmentioning

confidence: 99%

Is Bartonella a Cause of Primary Sclerosing Cholangitis? A Case Study

Kinderlehrer¹

2020

Gastrointestinal Disorders

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The etiology of primary sclerosing cholangitis (PSC) is unknown. I present a case which may be indicative of a causal link between Bartonella infection and PSC. The patient presented with complaints of abdominal pain and bloody diarrhea. A colonoscopy demonstrated chronic inflammation and changes consistent with ulcerative colitis. Routine laboratory studies revealed elevated liver function tests (LFTs); ultrasound and magnetic resonance imaging (MRI) confirmed the diagnosis of PSC. Bartonella serology was positive. It is established that Bartonella infection is associated with both gastrointestinal inflammation and autoimmunity; indeed, there is an animal model for Bartonella-induced PSC. Bartonella is susceptible to treatment with vancomycin and there are case reports and small series that demonstrate that PSC responds to treatment with oral vancomycin. Because of this, it is postulated that at least some cases of PSC may be associated with Bartonella infection. The patient in this report was treated with oral vancomycin and, since then, has been in remission for both colitis and PSC. Since vancomycin is not systemically absorbed, the premise is that he suffered from Bartonella colitis and an autoimmune reaction to Bartonella causing PSC. This premise warrants further study.

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A Triple Blinded, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis: a Pilot Study

Abstract: This study demonstrated an acceptable efficacy of vancomycin in the treatment of PSC.

Cited by 91 publications

References 0 publications

Review article: the evidence that vancomycin is a therapeutic option for primary sclerosing cholangitis

Review article: the evidence that vancomycin is a therapeutic option for primary sclerosing cholangitis

Novel and emerging therapies for cholestatic liver diseases

Is Bartonella a Cause of Primary Sclerosing Cholangitis? A Case Study

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