ClinicalTrials.Veeva

Menu

Therapy of Radiation Enteritis With Glutamine

N

Nanjing University School of Medicine

Status

Unknown

Conditions

Radiation Enteritis

Treatments

Drug: Glutamine

Study type

Interventional

Funder types

Other

Identifiers

NCT01758783
Radiation Enteritis 001

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups, including a placebo group

placebo group
Placebo Comparator group
Treatment:
Drug: Glutamine
Glutamine group
Experimental group
Treatment:
Drug: Glutamine

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems