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Effect of immunonutrient fortification on nutritional status and prognosis of patients with allo-HSCT: a single arm study

Effect of immunonutrient fortification on nutritional status and prognosis of patients with allo-HSCT: a single arm study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106405
Enrollment
Unknown
Registered
2025-07-23
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Blood system diseases

Interventions

Immunonutrition intervention group:Tumor total nutrition formula (Almanit) oral supplement, containing immunonutrients arginine, nucleotides, Omega-3 polyunsaturated fatty acids

Sponsors

The Second Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of hematological diseases (AML/ALL/MDS/AA/MM/NHL/HD); 2. Allogeneic hematopoietic stem cell transplantation is proposed; 3. Age between 10 and 70 years old; 4. Have language communication skills; 5. Willing to cooperate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Inability to take nutrition orally or through tube feeding; 2. Previous history of gastrointestinal surgery or other gastrointestinal treatment that affects nutrient absorption; 3. Other malignant tumors in the past 5 years (except for successfully treated in situ tumors); 4. Subjects have contraindications to enteral nutrition (e.g., active gastrointestinal bleeding, intestinal obstruction, decompensated short bowel syndrome, high-flow intestinal fistula, severe intraperitoneal infection, severe gastrointestinal emptying disorders, unstable vital signs, abnormal coagulation function, severe nausea, vomiting, and/or uncontrolled diarrhea/steatorrhea), and the above symptoms are uncorrectable in the opinion of the investigator; 5. Abnormal liver and kidney function (alanine aminotransferase ALT>=2 times the upper limit of normal value; Total bilirubin Tbil>=2 times the upper limit of normal; Creatinine Cr =2 times the upper limit of normal value); 6. Known history of hypothyroidism or hyperthyroidism; 7. Those who have tuberculosis or human immunodeficiency virus (HIV) infection; 8. Have mental disorders or uncontrolled mental illness 9. Known history of allergy or intolerance to any component of the investigational product; 10. Participated in another interventional clinical study, including nutritional support-related research, within 4 weeks before enrollment; Patients who are not suitable for this study in the opinion of the investigator (such as poor compliance, etc.).

Design outcomes

Primary

MeasureTime frame
Prevalence of severe malnutrition;Platelet Engraftment time;Neutrophil Engraftment time;

Secondary

MeasureTime frame
One-year OS rate;Transplantation-related mortality;Transplantation-related complications - incidence of acute graft-versus-host disease;Transplant-related complications - incidence of severe oral mucositis;Transplantation-related complications - infection rate;

Countries

China

Contacts

Public ContactQin Weiwei

The Second Affiliated Hospital of Air Force Medical University

vivianq1126@126.com+86 181 8265 7655

Outcome results

None listed

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