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A randomized controlled clinical study on the effects of immunonutrients on intestinal mucosal barrier and intestinal flora in patients with gastric cancer during perioperative period

A randomized controlled clinical study on the effects of immunonutrients on intestinal mucosal barrier and intestinal flora in patients with gastric cancer during perioperative period

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117170
Enrollment
Unknown
Registered
2026-01-20
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Immune nutrition treatment group:The patient takes supplementary immune nutrients daily (600 kcal per day before the surgery, and gradually adjusted to 600 kcal per day after the surgery according to
The general nutritional treatment group:The patient receives regular nutrients daily (preoperatively at 600 kcal per day, and gradually adjusted to 600 kcal per day after the surgery according to the

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. No gender restrictions; 2. No radiotherapy or chemotherapy within two weeks prior to screening; 3. Age 18-80 years (inclusive of 18 and 80); 4. Patients diagnosed with digestive tract tumors through histological or cytological examination and who have decided to undergo surgical treatment in the near future; 5. According to the investigator's judgment, patients requiring nutritional support treatment: (NRS2002 total score >= 3 points or unable to consume oral food to reach 60% of the recommended intake for more than one week); 6. Liver and kidney function: ALT and AST <= 2.5 times the upper limit of normal (for those with liver metastasis, <= 5 times the upper limit of normal); serum total bilirubin (TBIL) < 1.5 times the upper limit of normal; serum creatinine (SCr) < 1.5 times the upper limit of normal; 7. Able to tolerate enteral nutrition; 8. Voluntary and willing to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Unable to tolerate or unable to take orally or by tube feeding enteral nutrition; 2. Have diseases that severely affect the digestion and absorption of test substances; such as acute pancreatitis, gastrointestinal dysfunction, complete intestinal obstruction, digestive tract active bleeding, severe diarrhea, etc., patients with severe digestive and absorption dysfunction; 3. Are using nutritional preparations containing n-3 fatty acids, arginine, nucleotides, glutamine; 4. Are using drugs such as thymosin, glucocorticoids, thyroid hormone, growth hormone, anti-tumor necrosis factor, etc., which may enhance the body's immune function; 5. Have combined major organ dysfunction, multiple organ dysfunction or combined severe metabolic abnormalities; 6. Patients who have received non-surgical treatment recently; 7. Pregnant or lactating women; 8. Have a history of allergic reaction to the components of the test substance; 9. Researchers consider them unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Cellular immune indicators: total lymphocyte count, CD3 T cells, CD4 T cells, CD8 T cells, CD4/CD8 ratio, NK cells;Humoral immunity indicators: levels of immunoglobulins such as serum immunoglobulin A (IgA), serum immunoglobulin M (IgM), and immunoglobulin G (IgG);Intestinal mucosal barrier indicators: levels of plasma endotoxin (ET), D-lactic acid, and diamine oxidase (DAO);Inflammatory markers: total white blood cell count, total neutrophils, monocytes, platelets, high-sensitivity C-reactive protein;Pancreatic function indicators: fecal elastase-1 (PE-1), continuous glucose monitoring, oral glucose tolerance test (OGTT), pancreatic CT volume measurement;Nutritional indicators: body weight, body mass index (BMI), NRS2002, hemoglobin, albumin, prealbumin, grip strength, etc.;

Countries

China

Contacts

Public ContactKang Weiming

Peking Union Medical College Hospital

Kangweiming@163.com+86 138 1097 9989

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026