C18
Conditions
Interventions
Group 1: FMD group: Patients with Lynch syndrome perform a fasting-mimicking diet (FMD). Following colonoscopy and esophagogastroduodenoscopy as part of standard care, patients complete six 5-day FMD
Sponsors
Universitätsklinikum Bonn Medizinische Klinik und Poliklinik I
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Confirmed diagnosis of Lynch syndrome (pathogenic variant in MLH1, MSH2, MSH6, PMS2) • Age =18 years • Willingness to follow a fasting diet per protocol and ability to swallow plant foods • Body mass index (BMI) =20 kg/m2 • Written informed consent to participate in the study in accordance with the requirements of the local ethics committee • Willingness to provide blood and urine samples and participate in endoscopic examinations as per protocol • Willingness to put together and follow a diet • Willingness and ability to remain in contact with study staff by telephone or email to communicate important clinical information, including daily body weight, blood pressure, health status, and adverse events on each of the five days of the diet
Exclusion criteria
Exclusion criteria: • Diagnosed with Crohn's disease, colitis ulecerosa, active diverculitis • Active intestinal bleeding • Unintentional weight loss =5% during the last 3-6 months • Known HIV infection • for women: existing or planned pregnancy (positive pregnancy test, e.g. ß-HCG test in urine/serum/plasma) or breastfeeding • Diagnosis of type I or type II diabetes mellitus requiring drug therapy • Fasting glucose 200 mg/dL • Hemoglobin 7.0 mg/dl • Impaired kidney function (GFR below the normal range) • Impaired liver function (total bilirubin >2.0 mg/dl or AST/ALT 2 times ULN) • After colectomy • Known or ongoing abuse of medication, drugs or alcohol • Concurrent participation in another clinical trial or participation in a clinical trial with an investigational drug up to 120 days prior to participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Analysis of intestinal immune infiltrate and circulating immune cells o scRNA sequencing of PBMCs and intestinal immune cells o Multicolor flow cytometry of PBMCs and intestinal immune cells o IF and IHC of intestinal biopsy samples | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety of fasting diet (FMD) • Feasibility of fasting diet (FMD) • Metabolic effects of fasting diet (FMD) • Changes in the intestinal microbiome • Impact on gastrointestinal adenoma burden • Influence on body weight • Influence on blood count, liver values, retention parameters | — |
Countries
Germany
Contacts
Public ContactJacob Nattermann
Universitätsklinikum Bonn - Medizinische Klinik und Poliklinik I
Outcome results
None listed