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Active, Not Recruiting

NCT Number: NCT06026449

Gluten-free Diet in PSC and IBD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Sclerosing Cholangitis Bile Duct Diseases Biliary Disease Tract Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Disease Intestinal Diseases Ulcerative Colitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of clinical and experimental medicine

Prague, 14021, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten-free diet

Dietary Supplement

After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months

Primary outcomes

  1. Decrease of laboratory markers of cholestasis

    Time frame: 6-12 months

    Change of alkaline phosphatase > 25% or normalisation.

  2. Changes of intestinal microbiome composition.

    Time frame: 6-12 months

    16S-rRNA sequencing

Secondary outcomes

  1. Changes of morphological signs of intestinal inflammation

    Time frame: 6-12 months

    Endoscopic Mayo score (Grade 0 - normal or inactive disease; Grade 1 - mild disease acitivity; Grade 2 - moderate disease acitivity; Grade 3 - Severe disease acitivity)

  2. Improvement of quality of life and symptoms of ulcerative colitis.

    Time frame: 6-12 months

    UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire)

  3. Improvement of quality of life and symptoms of primary sclerosing cholangitis

    Time frame: 6-12 months

    PSC quality of life questionnaire (PSC PRO)

  4. Changes of histopathological signs of intestinal inflammation

    Time frame: 6-12 months

    Nancy histological index (Grade 0 - no histological significant disease; Grade 1 - chronic inflammatory infiltrate with no acute inflammatory infiltrate; Grade 2 - Mildly active disease, Grade 3 - Moderately active disease; Grade 4 - Severly active disease)

  5. Change from baseline of liver stiffness.

    Time frame: 6-12 months

    Shear-wave elastography (F0-F4)

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Collaborators

  • Czech Academy of Sciences

Registry information

Official study title

Effect of Gluten-free Diet on Clinical Symptoms, Immune Response and Microbiome in Primary Sclerosing Cholangitis and Inflammatory Bowel Disease

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 7, 2023
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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