Gluten-free Diet in PSC and IBD

Last updated: October 18, 2024
Sponsor: Institute for Clinical and Experimental Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Colic

Ulcers

Treatment

Gluten-free diet

Clinical Study ID

NCT06026449
NU22-06-00269
  • Ages 18-65
  • All Genders

Study Summary

Primary sclerosing cholangitis (PSC) is a progressive disease of the biliary tree, which represents one of the most frequent indications for orthotopic liver transplantation (OLTx) in developed countries. There are several lines of evidence that dietary gluten/gliadin displays chronic pro-inflammatory, LPS-like properties. Recent evidence demonstrated the protective effect of gluten- free diet (GFD) in autoimmune diseases like type 1 diabetes, irritable bowel syndrome, non-celiac gluten sensitivity and some neurological disorders. This study is intended to explore therapeutic effect of GFD on PSC and IBD in prospective self-controlled mono-centric intervention study.

Hypothesis: Avoidance of gluten in diet will reduce progression, symptoms and intestinal inflammation in PSC and UC patients.

Eligibility Criteria

Inclusion

Inclusion Criteria (for PSC group):

  • Established diagnosis of PSC (based on radiologic features, typical finding on MRCP or ERCP)

  • Age 18 - 65 years

  • ALP 1,5x higher than ULN

  • Signed informed consent

Exclusion Criteria (for PSC group):

  • Patients on gluten-free diet

  • Patients with coeliac disease or wheat allergy

  • Liver transplant recipients

  • PSC/AIH overlap syndrome

  • Other causes of liver disease

  • Radiologic or clinical signs of decompensated liver cirrhosis

  • Advanced liver cirrhosis (MELD score ˃ 15)

  • Recurrent acute cholangitis or cholangiogenic sepsis in past 3 months

  • Use of antibiotics in past 3 months

  • History of malignancy

  • Pregnant women

  • Not signed informed consent

Inclusion criteria (for UC group):

  • Ulcerative colitis diagnosed based on clinical, endoscopic and histological findings

  • Extension of affected colon > 15cm

  • Mayo score 0-4

  • Signed informed consent

Exclusion criteria (for UC group):

  • CMV, Clostridium difficile enterocolitis in past 3 months

  • Use of antibiotics in past 3 months

  • Patients with coeliac disease or wheat allergy

  • Patients on gluten-free diet

  • Pregnant women

  • Not signed informed consent

  • Biologic therapy

  • Methotrexate

  • Prednison > 10 mg

  • Not signed informed consent

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Gluten-free diet
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
August 30, 2026

Connect with a study center

  • Institute of clinical and experimental medicine

    Prague, 14021
    Czechia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.