Therapy of Radiation Enteritis With Glutamine
Primary Purpose
Radiation Enteritis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Glutamine
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Enteritis
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of chronic radiation enteritis
- Need the operation
- Malnutrition
Exclusion Criteria:
- Hepatic failure
- Kidney failure
- Neoplasm recurrence
- Serious cardiovascular/metabolic disease
- Pregnancy and lactation
Sites / Locations
- Department of Surgery, Nanjing General Hospital of Nanjing Command
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo group
Glutamine group
Arm Description
Outcomes
Primary Outcome Measures
inflammatory factor
Secondary Outcome Measures
Full Information
NCT ID
NCT01758783
First Posted
December 27, 2012
Last Updated
January 3, 2013
Sponsor
Nanjing University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01758783
Brief Title
Therapy of Radiation Enteritis With Glutamine
Official Title
the Efficacy of Glutamine in the Therapy of Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Enteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Title
Glutamine group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Glutamine
Intervention Description
amino acid:1.2-2g/(kg·d) Glutamine:0.5g /(kg·d)
Primary Outcome Measure Information:
Title
inflammatory factor
Time Frame
2 weeks after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of chronic radiation enteritis
Need the operation
Malnutrition
Exclusion Criteria:
Hepatic failure
Kidney failure
Neoplasm recurrence
Serious cardiovascular/metabolic disease
Pregnancy and lactation
Facility Information:
Facility Name
Department of Surgery, Nanjing General Hospital of Nanjing Command
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
Therapy of Radiation Enteritis With Glutamine
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