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Therapy of Radiation Enteritis With Glutamine

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Lei Zheng, Nanjing University School of Medicine Identifier:
First received: December 27, 2012
Last updated: January 3, 2013
Last verified: January 2013

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 Intervention
Radiation Enteritis
Drug: Glutamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: the Efficacy of Glutamine in the Therapy of Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.

Resource links provided by NLM:

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • inflammatory factor [ Time Frame: 2 weeks after the surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: 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 Identifier: NCT01758783     History of Changes
Other Study ID Numbers: Radiation Enteritis 001 
Study First Received: December 27, 2012
Last Updated: January 3, 2013
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on December 09, 2016