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Serine

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.

Table of contents

Clinical trials overview

The trial data for Serine shows three authorised Phase 3 interventional studies.[1][2][3] These studies are not testing Serine in a general population; they focus on patients with major emergency abdominal surgery, chronic hemodialysis, and oesophagectomy.[1][2][3]

Each study looks at a different nutrition-related question, such as infection risk, muscle protein building, or muscle loss after surgery.[1][2][3] The enrollment sizes range from 20 to 342 participants.[1][2][3]

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.[1] The study includes 342 participants and is authorised as a Phase 3 interventional trial.[1]

The main goal is to see whether early nutrition support can reduce infectious complications during the hospital stay.[1] Infectious complications means infections that happen while the patient is in the hospital after surgery.[1]

The interventions listed are SmofKabiven Perifer and SmofKabiven, both given by infusion as parenteral nutrition.[1] This means the nutrition is given through a vein rather than by mouth.[1]

Trial in chronic hemodialysis

The LOTUS study is a Phase 3 authorised trial in 20 patients with hemodialysis and muscle protein turnover concerns.[2] It studies IDPN, which stands for intradialytic parenteral nutrition, meaning nutrition given during dialysis.[2]

The main endpoint is the difference in myofibrillar fractional synthetic rate during one week of treatment with IDPN versus control.[2] This is a measure of how fast muscle protein is being made, so the study is looking at muscle building in people on dialysis.[2]

The brief summary also says the study will characterize the hemodynamic effects of IDPN.[2] Hemodynamic effects means effects on blood flow and circulation.[2]

Trial after oesophagectomy

The third study is called Route of nutrition and muscle wasting after oesophagectomy and includes 38 participants.[3] It is an authorised Phase 3 interventional trial that studies how the route of nutrition affects cachexia after oesophagectomy.[3]

The intervention listed is SmofKabiven emulsion for infusion, given by parenteral use.[3] The trial is designed to understand whether nutrition route changes muscle wasting, which means loss of muscle size or muscle mass.[3]

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.[3] A CT scan is an imaging test that shows detailed pictures inside the body.[3]

Main endpoints and what they mean

Across these studies, the endpoints focus on recovery after serious illness and surgery.[1][2][3] An endpoint is the main result a trial measures to see whether the treatment is helping.[1][2][3]

  • In the abdominal surgery trial, the endpoint is the rate of infectious complications during admission.[1]

  • In the hemodialysis trial, the endpoint is the difference in muscle protein synthesis over one week.[2]

  • In the oesophagectomy trial, the endpoint is the change in muscle size measured by CT scan after surgery.[3]

Who the trials are for

These studies are aimed at specific patient groups, not healthy volunteers.[1][2][3] One group has major emergency abdominal surgery, one group has chronic hemodialysis with muscle protein turnover concerns, and one group has undergone oesophagectomy.[1][2][3]

Because the studies are Phase 3, they are meant to provide more detailed evidence in real patient care settings.[1][2][3] The source data does not list detailed inclusion or exclusion rules, so the exact entry criteria are not available here.[1][2][3]

Trial ID Phase Condition studied Status Enrollment Main endpoint
2023-505378-14-00 Phase 3 Major emergency abdominal surgery Authorised 342 Reduction in infectious complications during admission
2025-522111-42-02 Phase 3 Muscle protein turnover; hemodialysis Authorised 20 Difference in myofibrillar fractional synthetic rate during one week of treatment
2023-507649-27-00 Phase 3 Oesophagectomy Authorised 38 Mean difference in muscle size by CT scan from before to 10 days after surgery

FAQ

  • What is being studied in clinical trials of Serine? The trials are studying nutrition-related treatments in patients after major emergency abdominal surgery, after oesophagectomy, and in chronic hemodialysis. The main goals are to measure infection risk, muscle protein synthesis, muscle size, and hemodynamic effects.
  • Who may take part in these Serine trials? The target groups are patients with major emergency abdominal surgery, patients after oesophagectomy, and chronic hemodialysis patients. These are specific adult medical groups, not general healthy volunteers.
  • What phase are the Serine trials in? All three trials are Phase 3 studies. Phase 3 trials usually compare treatments in larger patient groups to see how well they work and to collect more detailed clinical data.
  • What outcomes are the trials measuring? One trial measures infectious complications during hospital stay, one measures myofibrillar fractional synthetic rate, and one measures muscle size by CT scan. One trial also looks at hemodynamic effects, which means effects on blood flow and circulation.
  • Are these trials already recruiting? The status for all three listed trials is Authorised. That means the studies have been approved, but the data provided here does not say whether each one is currently recruiting.

Ongoing Clinical Trials on Serine

  • Study of Intradialytic Parenteral Nutrition for Muscle Protein Production in Patients on Long-term Hemodialysis Treatment

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Nutrition Methods and Muscle Loss After Esophagectomy Using SmofKabiven and Drug Combination for Patients Recovering from Esophageal Surgery

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Early vs. Delayed Supplementary Parenteral Nutrition with SmofKabiven for Patients After Major Emergency Abdominal Surgery

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Phase 3: A later stage of clinical research that tests a treatment in larger patient groups to learn more about how well it works.
  • Interventional study: A study where researchers give a treatment or compare treatments and then measure the effects.
  • Parenteral nutrition: Nutrition given through a vein instead of by mouth or through the stomach.
  • Supplementary parenteral nutrition: Extra nutrition given through a vein in addition to usual feeding.
  • Hemodialysis: A treatment that filters the blood when the kidneys are not working well.
  • Myofibrillar fractional synthetic rate: A measure of how fast muscle protein is being made in the body.
  • CT-scan: A special imaging test that takes detailed pictures of the inside of the body.
  • Muscle wasting: Loss of muscle size or muscle mass, often seen in serious illness.
  • Cachexia: A condition of severe weight and muscle loss linked to serious disease.
  • Hemodynamic effects: Effects on blood flow, blood pressure, and circulation.

References

  1. https://clinicaltrials.gov/study/2023-505378-14-00
  2. https://clinicaltrials.gov/study/2025-522111-42-02
  3. https://clinicaltrials.gov/study/2023-507649-27-00