Therapy of Radiation Enteritis With Glutamine
- Registration Number
- NCT01758783
- Lead Sponsor
- Nanjing University School of Medicine
- Brief Summary
Objective: To evaluate the effects of perioperative glutamine supplemented total parenteral nutrition support on nutritional status, immunologic function and intestinal permeability of patients with chronic radiation intestinal injury.
Methods: The 40 patients with CRII were randomized into two groups, the standard TPN group and glutamine-enriched TPN group. The patients were administered total parenteral nutrition for at least four weeks (two weeks pre-operation and two weeks post-operation). The nutritional status, immunologic function, plasma concentration of glutamine and intestinal permeability were measured at 1 day, 1 week and 2 weeks pre-operation, 3 day, 1 week and 2 weeks post-operation. Nutrition status was determined the plasma concentrations of hemoglobin, albumin, prealbumin, transferrin and triglyceride. Immunologic function were measured by the percentages of CD4+T cells and CD8+T cells, the ratio of CD4 +T cells to CD8+T cells ( CD4 +/CD8 +) was calculated， and serum IgA, IgM and IgG．The intestinal permeability was detected by the urinal ratio of lactulose and mannitol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Clinical diagnosis of chronic radiation enteritis
- Need the operation
- Malnutrition
- Hepatic failure
- Kidney failure
- Neoplasm recurrence
- Serious cardiovascular/metabolic disease
- Pregnancy and lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group Glutamine - Glutamine group Glutamine -
- Primary Outcome Measures
Name Time Method inflammatory factor 2 weeks after the surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Surgery, Nanjing General Hospital of Nanjing Command
🇨🇳Nanjing, Jiangsu, China