Lynch syndrome (ORPHA:144 )
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Genetically confirmed Lynch syndrome - Age = 18 years - Ability to swallow plant-based foods - Body mass index (BMI) = 20 kg/m2 - Haemoglobin > 9 g/dl - Normal leucocytes - Creatinine 65 mg/dl - Total bilirubin < 2 mg/dl or < ULN - Written informed consent - Willingness and ability to perform blood, stool and urine tests Ability to remain in daily contact (by phone or email) with study personnel to communicate important clinical information, including daily body weight, blood pressure, health status and adverse events during the diet
Exclusion criteria
Exclusion criteria: - Unintentional weight loss = 5% in the last 3-6 months - Known HIV infection - Existing or planned pregnancy (positive pregnancy test in women, e.g. ß-HCG test in urine/serum) or breastfeeding - Diagnosis of type I or type II diabetes mellitus requiring medical treatment - Fasting glucose > 200 mg/dl - Impaired renal function (creatinine > 1.5mg/dl; GFR 2 mg/dl or AST/ALT 2-fold ULN - Post complete colectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of the intestinal immune infiltrate and circulating immune cells at the time of the routine monitoring endoscopy after the respective diet phase o scRNA sequencing of PBMCs and intestinal immune cells o Multicolour flow cytometry of PBMCs and intestinal immune cells o IF and IHC of intestinal biopsy samples | — |
Secondary
| Measure | Time frame |
|---|---|
| - Metabolic effects of the vegan diet - Changes in the intestinal microbiome - Influence on gastrointestinal adenoma load - Influence on body weight - Influence on blood count, liver values, retention parameters at the time of the routine monitoring endoscopy after the respective diet phase | — |
Countries
Germany
Contacts
Universitätsklinikum Bonn Medizinische Klinik und Poliklinik I