Gluten-free Diet in PSC and IBD

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06026449
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institute for Clinical and Experimental Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Czechia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Sclerosing Cholangitis, Ulcerative Colitis, Biliary Tract Diseases, Biliary Disease Tract, Intestinal Disease

Arms & Interventions

Arms

Experimental: Primary sclerosing cholangitis

Experimental: Ulcerative Colitis

Interventions

Dietary Supplement: - Gluten-free diet

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Prague, Czechia

Status

Recruiting

Address

Institute of clinical and experimental medicine

Prague, , 14021

Site Contact

Jan Brezina, M.D.

jan.brezina@ikem.cz

00420739602520

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