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Therapy of Radiation Enteritis With Glutamine

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Lei Zheng, Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01758783
First received: December 27, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

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

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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758783

Locations
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

No publications provided

Responsible Party: Lei Zheng, Resident, Nanjing University School of Medicine
ClinicalTrials.gov 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:
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 18, 2013