Anorexia en sarcopenia
Conditions
Interventions
Patients will be treated with infusion of either allogenic or autologous
microbial transplantation by duodenoal tube after bowel lavage. Bowel lavage is
performed by drinking 3-4 liter Klean Prep de
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Recipients: - Male or female with metastasized or locally advanced oesophageal and/or gastric cancer receiving standard first-line palliative chemotherapy (capecitabine and platinum-containing therapy) - Age >18 years old - Meeting the criteria for sarcopenia, using computed tomography (CT)-scan: the L3 muscle area surfaces will be normalized for patient height to calculate the L3 muscle index and expressed in cm2/m2. The cutoff values used for sarcopenia are 52.4 cm2/m2 for men and 38.5 cm2/m2 for women, based on the method of Prado et al1 - Meeting the International Classification of Functioning, Disability and Health (ICF), WHO 1, 2 or 3. - Stable medication use, all subjects use PPI. - Subjects should be able and willing to give informed consent;Donors: - Obese otherwise healthy caucasian male or female - BMI >25 kg/m2
Exclusion criteria
Exclusion criteria: Recipients: - XTC, amphetamine or cocaine abuse - Alcohol abuse (>3/day) - Cholecystectomy - HIV infection with a CD4 count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Faecal gut microbiota composition (morning stool samples) Satiety, measured by: 1. Visual Analog Scale (VAS) 2. Plasma markers for satiety (tryptophan, ghrelin, leptin, neuropeptide Y and orexin levels) 3. Energy expenditure, measured by indirect calorimetry. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Sarcopenia (muscle mass measured by CT-based analysis and grip strength) - Body composition (measured by Bio Impedance Analysis) - Faecal energy excretion (caloric bomb method) and short chain fatty acid and bile acid concentration (2x24h collected faeces) and urine excretion of 5-HIAA (24 h collected urine). - Systemic inflammation and gut barrier function (CRP, plasma interleukins/LPS binding protein levels and fecal calprotectin) in relation to energy metabolism as measured by resting energy expenditure (REE). - Chemotherapy toxicity, graded with the Common Terminology Criteria for Adverse Events (CTCAE)11 - Treatment response measured by CT-scan at baseline and after the first 3 cycles of chemotherapy (week 12). - Overall survival (defined as the number of days of survival after PA diagnosis). | — |
Countries
Netherlands
Outcome results
None listed