Chyme Reinfusion for Type 2 Intestinal Failure

Inclusion Criteria:

• Age ≥ 21 years

• Able to provide written informed consent

• Dependent on parenteral nutrition (PN)

• DES/ECF with exposed afferent and efferent limbs visible on the abdominal wall

• Minimum of 2 weeks post DES/ECF creation

• Distal limb of DES/ECF opening can be intubated by a minimum 24Fr feeding tube (dilatation of orifice strictures is allowable)

Exclusion Criteria:

• Insufficient distal access channel (distal limb) for device insertion

• Bowel obstruction proximal to the DES/ECF

• Small bowel obstruction, anastomotic leak, or perforation distal to the DES/ECF (diagnostic procedure such as gastrografin test, fistulograms, or similar must beperformed, if there is a distal anastomosis with integrity not previously evaluated,to ensure that the subject is eligible)

• Scheduled for DES/ECF reversal within 4 weeks of enrolment date

• Current infection with Clostridium difficile colitis

• Current infection small intestinal bacterial overgrowth (SIBO)

• Signs or symptoms of systemic infection

• Pre-existing gastrointestinal motility disorders including slow transitconstipation, outlet obstruction, fecal incontinence, and gastroparesis

• Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility,e.g., multiple sclerosis, Parkinson's disease, hypothyroidism

• Known peritoneal metastatic disease prior to DES/ECF closure (acceptable if onlydiscovered at time of closure)

• Liver cirrhosis

• Hereditary coagulopathy, e.g., von Willebrand disease

• Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2)

• Active implantable medical devices such as neuromodulation and cardiac systems

• Metal stents implanted within 20cm of expected use of the controller

• Women who are pregnant or breastfeeding

• Subjects participating in an interventional clinical study within 30 days prior torandomization