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Vegan diet in hereditary tumour syndromes

Vegan diet in hereditary tumour syndromes - VEGTUS-1

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035540
Enrollment
75
Registered
2024-12-13
Start date
2025-03-03
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lynch syndrome (ORPHA:144 )

Interventions

Sponsors

Universitätsklinikum Bonn Medizinische Klinik und Poliklinik I
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactJacob Nattermann

Universitätsklinikum Bonn Medizinische Klinik und Poliklinik I

jacob.nattermann@ukbonn.de+49 228 287-15260

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026