Skip to content

Effects of enteral nutrition and intestinal flora regulators on immune checkpoints in patients with digestive system tumors

Effects of enteral nutrition and intestinal flora regulators on immune checkpoints in patients with digestive system tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035037
Enrollment
Unknown
Registered
2020-07-28
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-03

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

Conditions

gastrointestinal tumors

Interventions

experimental group 1:Ruineng enteral nutritional emulsion
experimental group 2:Dongzeli probiotic powder
experimental group 3:Ruineng enteral nutritional emulsion and Dongzeli probiotic powder

Sponsors

Lanzhou University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in the trial and sign the informed consent; 2. According to clinical symptoms, signs and related imaging, pathological examination, as well as tumor markers, patients were definitely diagnosed as gastrointestinal tumors, including esophageal cancer, gastric cancer, duodenal cancer, liver cancer, gallbladder cancer, pancreatic cancer, colorectal cancer. 3.Patients with malignant tumors that cannot be treated by surgery and require transformation therapy or neoadjuvant therapy; 4. Those who have not taken antibiotics in the past 1 month; 5. With my consent and signed informed consent, I am willing and able to comply with the planned visit, research treatment, laboratory examination and other test procedures.

Exclusion criteria

Exclusion criteria: 1. Those who have received systematic treatment (including neoadjuvant chemotherapy, novel molecular targeted therapy and immunotherapy) before admission; 2. Used antibiotics in the past 1 month; 3. Severe active infections requiring intravenous antibiotic therapy occur during enrollment; 4. Those who cannot tolerate enteral nutrition; 5. Patients with intestinal obstruction and unable to eat; 6. Having multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, etc.); 7. History of splenectomy or thymus resection; 8. ICU admission due to critical condition; 9. Patients with any severe and/or uncontrolled disease, including: (1) A hypotensive drug is still not optimally controlled (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg); (2) Patients with grade I or higher myocardial ischemia or myocardial infarction, malignant arrhythmias (including QTC >= 480ms), and grade 2 or higher congestive heart failure (NYHA classification); (3) Decompensated liver disease; (4) Renal failure requires hemodialysis or peritoneal dialysis); (5) Have a history of immunodeficiency, including those who are HIV positive or have other acquired or congenital immunodeficiency disorders, or have a history of organ transplantation; (6) Poor diabetes control (fasting blood glucose (FBG)> 10mmol / L); (7) Patients with seizures who need treatment; 10. People with ineffectively controlled, symptomatic brain metastases, or a history of uncontrollable mental illness; Severe intellectual or cognitive dysfunction; 11. Subjects in need of systemic corticosteroids or other immunosuppressive drugs within 14 days prior to randomization; 12. Patients the investigator considers inappropriate.

Design outcomes

Primary

MeasureTime frame
intestinal flora;Immune checkpoints;Evaluation of immune function;

Countries

China

Contacts

Public ContactChen Hao

Lanzhou University Second Hospital

ery_chenh@lzu.edu.cn+86 15009467790

Outcome results

None listed

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