Biliary Disease Tract, Biliary Tract Diseases, Intestinal Disease, Primary Sclerosing Cholangitis, Ulcerative Colitis
Conditions
Keywords
Primary sclerosing cholangitis, Cholangitis, Gluten-free diet, Ulcerative Colitis, Microbiome
Brief 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.
Interventions
DIETARY_SUPPLEMENTGluten-free diet
After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months
Sponsors
Czech Academy of Sciences
Institute for Clinical and Experimental Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, self-controlled pilot clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease of laboratory markers of cholestasis | 6-12 months | Change of alkaline phosphatase \> 25% or normalisation. |
| Changes of intestinal microbiome composition. | 6-12 months | 16S-rRNA sequencing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of morphological signs of intestinal inflammation | 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) |
| Improvement of quality of life and symptoms of ulcerative colitis. | 6-12 months | UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire) |
| Improvement of quality of life and symptoms of primary sclerosing cholangitis | 6-12 months | PSC quality of life questionnaire (PSC PRO) |
| Changes of histopathological signs of intestinal inflammation | 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) |
| Change from baseline of liver stiffness. | 6-12 months | Shear-wave elastography (F0-F4) |
Countries
Czechia
Outcome results
None listed