Gluten-free Diet in PSC and IBD (NCT06026449) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Gluten-free Diet in PSC and IBD
Czechia60 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decrease of laboratory markers of cholestasis
Timeframe: 6-12 months
2
Changes of intestinal microbiome composition.
Timeframe: 6-12 months
Trial details
NCT IDNCT06026449
SponsorInstitute for Clinical and Experimental Medicine