Primary Sclerosing CholangitisNCT06026449
Gluten-free Diet in PSC and IBD
A study testing Gluten-free diet in people with Primary Sclerosing Cholangitis and Ulcerative Colitis, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Sclerosing Cholangitis, Ulcerative Colitis, Biliary Tract Diseases
- What is being tested?
- Gluten-free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2023to 31 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Ulcerative colitis diagnosed based on clinical, endoscopic and histological findings
- Extension of affected colon > 15cm
- Mayo score 0-4
- Signed informed consent
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Gluten-free Diet on Clinical Symptoms, Immune Response and Microbiome in Primary Sclerosing Cholangitis and Inflammatory Bowel Disease
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.
- Conditions
- Primary Sclerosing Cholangitis, Ulcerative Colitis, Biliary Tract Diseases, Biliary Disease Tract, Intestinal Disease
- Being tested
- Gluten-free diet
- Keywords
- Primary sclerosing cholangitis, Cholangitis, Gluten-free diet, Ulcerative Colitis, Microbiome
- Medical subject headings
- Cholangitis, Sclerosing, Colitis, Ulcerative, Biliary Tract Diseases, Intestinal Diseases, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten-free dietDietary supplement
After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months
| Study group | Role | What they receive |
|---|---|---|
| Primary sclerosing cholangitis | Experimental | Not described Receives: Dietary Supplement: Gluten-free diet |
| Ulcerative Colitis | Experimental | Not described Receives: Dietary Supplement: Gluten-free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of laboratory markers of cholestasis
Change of alkaline phosphatase > 25% or normalisation.
Measured: 6-12 months
Changes of intestinal microbiome composition.
16S-rRNA sequencing
Measured: 6-12 months
Secondary outcomes (5)
Changes of morphological signs of intestinal inflammation
Endoscopic Mayo score (Grade 0 - normal or inactive disease; Grade 1 - mild disease acitivity; Grade 2 - moderate disease acitivity; Grade 3 - Severe disease acitivity)
Measured: 6-12 months
Improvement of quality of life and symptoms of ulcerative colitis.
UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire)
Measured: 6-12 months
Improvement of quality of life and symptoms of primary sclerosing cholangitis
PSC quality of life questionnaire (PSC PRO)
Measured: 6-12 months
Changes of histopathological signs of intestinal inflammation
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)
Measured: 6-12 months
Change from baseline of liver stiffness.
Shear-wave elastography (F0-F4)
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Jan 2023
- Primary completion7 Jan 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, self-controlled pilot clinical trial
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Collaborators
- Czech Academy of Sciences
- Responsible party
- Principal investigator, Jan Březina, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026449
- Sponsor's protocol ID
- NU22-06-00269
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No