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
- Are there results?
- None posted in the registry
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
Show all 22Show fewer
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
Publications
Kordac P, Hajek M, Cahova M, Hlavaty M, Sedivy P, Dezortova M, Pajuelo D, Balusikova K, Brezina J, Drastich P. Paradoxical hepcidin-iron dysregulation in primary sclerosing cholangitis. PLoS One. 2026 Oct 27;21(10):e0361385. doi: 10.1371/journal.pone.0361385. eCollection 2026.
PubMed 42945308
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gluten-free Diet on Clinical Symptoms, Immune Response and Microbiome in Primary Sclerosing Cholangitis and Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06026449
- Acronym / sponsor ID
- NU22-06-00269
- Conditions
- Primary Sclerosing Cholangitis, Ulcerative Colitis, Biliary Tract Diseases, Biliary Disease Tract, Intestinal Disease
- Keywords
- Primary sclerosing cholangitis, Cholangitis, Gluten-free diet, Ulcerative Colitis, Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Collaborators
- Czech Academy of Sciences
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, self-controlled pilot clinical trial
| Arm | Type | Receives |
|---|---|---|
| Primary sclerosing cholangitis | Experimental | Dietary Supplement: Gluten-free diet |
| Ulcerative Colitis | Experimental | Dietary Supplement: Gluten-free diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (22 listed)
- Patients on gluten-free diet
- Patients with coeliac disease or wheat allergy
- Liver transplant recipients
- PSC/AIH overlap syndrome
- Other causes of liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten-free dietAfter initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months | Dietary supplement | Primary sclerosing cholangitis, Ulcerative Colitis |
Primary outcome
Decrease of laboratory markers of cholestasis
Time frame: 6-12 months
Change of alkaline phosphatase > 25% or normalisation.
Changes of intestinal microbiome composition.
Time frame: 6-12 months
16S-rRNA sequencing
5 secondary outcomes
Changes of morphological signs of intestinal inflammation
Time frame: 6-12 months
Improvement of quality of life and symptoms of ulcerative colitis.
Time frame: 6-12 months
Improvement of quality of life and symptoms of primary sclerosing cholangitis
Time frame: 6-12 months
Changes of histopathological signs of intestinal inflammation
Time frame: 6-12 months
Change from baseline of liver stiffness.
Time frame: 6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 42945308Kordac P, Hajek M, Cahova M, Hlavaty M, Sedivy P, Dezortova M, Pajuelo D, Balusikova K, Brezina J, Drastich P. Paradoxical hepcidin-iron dysregulation in primary sclerosing cholangitis. PLoS One. 2026 Oct 27;21(10):e0361385. doi: 10.1371/journal.pone.0361385. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Primary Sclerosing Cholangitis
RecruitingObservational study
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
Primary Sclerosing Cholangitis
Not yet recruitingPhase 2
FEAST and HOPE: Redox PSC Pilot Study
Primary Sclerosing Cholangitis (PSC)
RecruitingPhase 3
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of laboratory markers of cholestasis (time frame: 6-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06026449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.