Effect of Fecal Transplantation on Satiety, Sarcopenia, Inflammation and Chemotherapy Toxicity in patients with Metastasized Oesophageal and Gastric Cancer.
- Conditions
- Anorexia en sarcopenia1000301810028302
- Registration Number
- NL-OMON43382
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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
Recipients:
- XTC, amphetamine or cocaine abuse
- Alcohol abuse (>3/day)
- Cholecystectomy
- HIV infection with a CD4 count < 240
- Patients with diabetes mellitus (there are several studies indicating that a high level of NLR may reflect ongoing vascular inflammation and play an important role in the pathophysiology of DM and even prediabetes). ;Donors:
- Presence of chronic low grade inflammation or criteria of metabolic syndrome
- Use of any medication including PPI and antibiotics
- Presence of type 2 diabetes or hypertension
- Diarrhoea
- Cholecystectomy
- HIV, HAV, HBV, HCV, active CMV, active EBV, IBD
- Unsafe sex practice (questionnaire)
- Presence of faecal bacterial pathogens (salmonella, Shigella, Campylobacter, Yersinia), virus (Rotavirus, Noroviru, enterovirus, parechovirus, sapovirus, adenovirus, astrovirus) or parasites
- Positive C. difficile stool test
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Faecal gut microbiota composition (morning stool samples)<br /><br>Satiety, measured by: 1. Visual Analog Scale (VAS) 2. Plasma markers for<br /><br>satiety (tryptophan, ghrelin, leptin, neuropeptide Y and orexin levels) 3.<br /><br>Energy expenditure, measured by indirect calorimetry. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Sarcopenia (muscle mass measured by CT-based analysis and grip strength)<br /><br>- Body composition (measured by Bio Impedance Analysis)<br /><br>- Faecal energy excretion (caloric bomb method) and short chain fatty acid and<br /><br>bile acid concentration (2x24h collected faeces) and urine excretion of 5-HIAA<br /><br>(24 h collected urine).<br /><br>- Systemic inflammation and gut barrier function (CRP, plasma interleukins/LPS<br /><br>binding protein levels and fecal calprotectin) in relation to energy<br /><br>metabolism as measured by resting energy expenditure (REE).<br /><br>- Chemotherapy toxicity, graded with the Common Terminology Criteria for<br /><br>Adverse Events (CTCAE)11<br /><br>- Treatment response measured by CT-scan at baseline and after the first 3<br /><br>cycles of chemotherapy (week 12).<br /><br>- Overall survival (defined as the number of days of survival after PA<br /><br>diagnosis). </p><br>