In short
Clinical trials investigating Serine are studying nutrition-related treatments in people after major abdominal surgery, after oesophagectomy, and in chronic hemodialysis. These trials aim to understand effects on infection risk, muscle protein synthesis, muscle size, and hemodynamic effects. All listed studies are Phase 3 and involve adult patient groups with serious medical conditions.
Key points
- Clinical trials investigating Serine are focused on nutrition-related care in serious illness. The listed studies include patients after major emergency abdominal surgery, after oesophagectomy, and people on chronic hemodialysis. All three trials are Phase 3 and are designed to measure outcomes such as infections, muscle protein synthesis, muscle size, and circulation-related effects. The studies are authorised and include small to moderate patient groups, with enrollments ranging from 20 to 342. Together, they aim to learn whether different nutrition strategies can improve recovery and reduce complications.
Clinical trials overview
The trial data for Serine shows three authorised Phase 3 interventional studies. These studies are not testing Serine in a general population; they focus on patients with major emergency abdominal surgery, chronic hemodialysis, and oesophagectomy.
Each study looks at a different nutrition-related question, such as infection risk, muscle protein building, or muscle loss after surgery. The enrollment sizes range from 20 to 342 participants.
Trials after emergency abdominal surgery
The first study, Early versus postponed supplementary parenteral nutrition after major emergency abdominal surgery, compares early and delayed supplementary parenteral nutrition. The study includes 342 participants and is authorised as a Phase 3 interventional trial.
The main goal is to see whether early nutrition support can reduce infectious complications during the hospital stay. Infectious complications means infections that happen while the patient is in the hospital after surgery.
The interventions listed are SmofKabiven Perifer and SmofKabiven, both given by infusion as parenteral nutrition. This means the nutrition is given through a vein rather than by mouth.
Trial in chronic hemodialysis
The LOTUS study is a Phase 3 authorised trial in 20 patients with hemodialysis and muscle protein turnover concerns. It studies IDPN, which stands for intradialytic parenteral nutrition, meaning nutrition given during dialysis.
The main endpoint is the difference in myofibrillar fractional synthetic rate during one week of treatment with IDPN versus control. This is a measure of how fast muscle protein is being made, so the study is looking at muscle building in people on dialysis.
The brief summary also says the study will characterize the hemodynamic effects of IDPN. Hemodynamic effects means effects on blood flow and circulation.
Trial after oesophagectomy
The third study is called Route of nutrition and muscle wasting after oesophagectomy and includes 38 participants. It is an authorised Phase 3 interventional trial that studies how the route of nutrition affects cachexia after oesophagectomy.
The intervention listed is SmofKabiven emulsion for infusion, given by parenteral use. The trial is designed to understand whether nutrition route changes muscle wasting, which means loss of muscle size or muscle mass.
The primary outcome is the mean difference in muscle size measured by CT scan from before surgery to 10 days after oesophagostomy, as written in the source data. A CT scan is an imaging test that shows detailed pictures inside the body.
Main endpoints and what they mean
Across these studies, the endpoints focus on recovery after serious illness and surgery. An endpoint is the main result a trial measures to see whether the treatment is helping.
- In the abdominal surgery trial, the endpoint is the rate of infectious complications during admission.
- In the hemodialysis trial, the endpoint is the difference in muscle protein synthesis over one week.
- In the oesophagectomy trial, the endpoint is the change in muscle size measured by CT scan after surgery.
Who the trials are for
These studies are aimed at specific patient groups, not healthy volunteers. One group has major emergency abdominal surgery, one group has chronic hemodialysis with muscle protein turnover concerns, and one group has undergone oesophagectomy.
Because the studies are Phase 3, they are meant to provide more detailed evidence in real patient care settings. The source data does not list detailed inclusion or exclusion rules, so the exact entry criteria are not available here.