Reduction of Intestinal Inflammatory Activity
Conditions
Brief summary
Gluten is a protein found in wheat and other cereals as barley and rye. It triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. Alpha-amylase/trypsin inhibitors (ATIs) of wheat seem to be the responsible trigger of this intestinal Inflammation. Intestinal inflammation is connected to other extra-intestinal autoimmune inflammations like PSC (as f.ex. the association of PSC with inflammatory bowel disease proves). Hypothesis: Avoidance of ATIs through a gluten-free diet will reduce intestinal inflammation and thus also the the inflammatory activity in the liver. Proof of hypothesis: * Pilot study with n=20 patients with PSC * Explorative, open-label, mono-centric study * Inclusion criteria: age 18-65, diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.
Interventions
DIETARY_SUPPLEMENTGluten-free diet
After run-in phase with normal diet under Observation, patients will be on a gluten-free diet for two months.
Sponsors
Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel
Johannes Gutenberg University Mainz
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.
Exclusion criteria
* patients with coeliac disease or wheat allergy * patients with active colitis * patients already on gluten-free diet * liver transplanted patients * patients also diagnosed with autoimmune hepatites (PSC-AIH overlap) * coloscopy within 2 months before study * Endoscopic retrograde cholangiopancreatography (ERCP) within 3 months before study * antibiotics within 3 month before study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of intestinal inflammatory activity | 2 months | Expression of pro-inflammatory cytokines in gut mucosa (Sigma) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory activity of the liver | 2 months | alkaline phosphatase (AP) |
| Reduction of inflammatory cells/markers in the blood | 2 months | stored blood samples, Pax-Gene |
| Quality of life | 2 months | questionnaire |
| Change of symptoms with change of diet. | 2 months | questionnaire |
| Changes in patients microbiota | 2 months (5 months with follow-up) | stool samples |
Countries
Germany
Outcome results
None listed