Effect of Fecal Transplantation on Satiety, Sarcopenia, Inflammation and Chemotherapy Toxicity in patients with Metastasized Oesophageal and Gastric Cancer. - TRANSIT-study

Academisch Medisch Centrum0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•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

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