Therapy of Radiation Enteritis With Glutamine

Radiation Enteritis Clinical Trial

Official title:

the Efficacy of Glutamine in the Therapy of Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01758783
• Other study ID #: Radiation Enteritis 001
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 27, 2012
• Last updated: January 3, 2013
• Start date: June 2012
• Est. completion date: July 2013

Study information

• Verified date: January 2013
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enteritis
• Radiation Enteritis

Intervention

Drug:
• Glutamine
amino acid:1.2-2g/(kg·d) Glutamine:0.5g /(kg·d)

Locations

Country	Name	City	State
China	Department of Surgery, Nanjing General Hospital of Nanjing Command	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory factor		2 weeks after the surgery	Yes