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A prospective randomized controlled clinical study of the effects of enteral nutrition with immunonutrients on perioperative disease immunity and intestinal mucosal barrier in patients with gastrointestinal tumors

A prospective randomized controlled clinical study of the effects of enteral nutrition with immunonutrients on perioperative disease immunity and intestinal mucosal barrier in patients with gastrointestinal tumors

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084026
Enrollment
Unknown
Registered
2024-05-09
Start date
2023-08-05
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Gastrointestinal tumor

Interventions

Experimental group:immunonutrient
Control group:Common nutrient

Sponsors

Peking Union Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Gender is not limited 2. Over 18 years old, under 80 years old 3. Histologically or cytologically diagnosed patients with gastrointestinal tumors who have recently decided to undergo surgical treatment 4. Patients who, according to the investigators' judgment, need nutritional support therapy: (NRS2002 score =3 or expected to be unable to eat 60% of the recommended intake through mouth for more than 1 week 5. Liver and kidney function: ALT, AST=2.5 times the normal upper limit (with liver metastasis =5 times the normal upper limit) Serum total bilirubin (TBIL) was less than 1.5 times the normal upper limit. Serum creatinine (SCr) < 1.5 times the upper limit of normal Serum triglyceride (TG) < 1.5 times the normal upper limit 6. Those who can tolerate enteral nutrition 7. Voluntary consent and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Can not tolerate or cannot oral/tube feeding enteral nutrition; 2. Diseases that seriously affect the digestion and absorption of test materials; Such as acute pancreatitis, gastrointestinal failure, complete intestinal obstruction, gastrointestinal active bleeding, severe diarrhea and other patients with severe digestive and absorption dysfunction; 3. Those who are using nutrition preparations containing n-3 fatty acid milk, arginine, nucleotide and glutamine; 4. Those who are using thymosin, glucocorticoids, thyroxine, growth hormone, anti-tumor necrosis factor and other drugs that may enhance the immune function of the body; 5. Patients with major organ dysfunction, multiple organ dysfunction, or severe metabolic abnormalities; 6, patients with recent non-surgical treatment; 7. Pregnant or lactating women or fertile women with positive baseline pregnancy test; 8. Allergic to sample ingredients; 9. The researcher considers that it is not suitable to participate in this research

Design outcomes

Primary

MeasureTime frame
Intestinal barrier index;Immune cell number/ratio;Immune protein content;C reactive protein;

Secondary

MeasureTime frame
Albumin/prealbumin;Physical measurement indicators (including height, weight, body fat measurement, etc.);

Countries

China

Contacts

Public ContactWeiming Kang

Peking Union Hospital, Chinese Academy of Medical Sciences

kangwieming@163.com+86 138 1097 9989

Outcome results

None listed

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