We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Therapy of Radiation Enteritis With Glutamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01758783
Recruitment Status : Unknown
Verified January 2013 by Lei Zheng, Nanjing University School of Medicine.
Recruitment status was:  Enrolling by invitation
First Posted : January 1, 2013
Last Update Posted : January 4, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Radiation Enteritis Drug: Glutamine

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: the Efficacy of Glutamine in the Therapy of Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
Study Start Date : June 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo group Drug: Glutamine
amino acid:1.2-2g/(kg·d) Glutamine:0.5g /(kg·d)
Experimental: Glutamine group Drug: Glutamine
amino acid:1.2-2g/(kg·d) Glutamine:0.5g /(kg·d)

Outcome Measures

Primary Outcome Measures :
  1. inflammatory factor [ Time Frame: 2 weeks after the surgery ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758783

China, Jiangsu
Department of Surgery, Nanjing General Hospital of Nanjing Command
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Nanjing University School of Medicine
More Information

Responsible Party: Lei Zheng, Resident, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT01758783     History of Changes
Other Study ID Numbers: Radiation Enteritis 001
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases