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Status unknownNCT01758783Updated Jan 4, 2013

Therapy of Radiation Enteritis With Glutamine

An interventional study of Glutamine in Radiation Enteritis, sponsored by Nanjing University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-01-04.

Sponsored by Nanjing University School of Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • Radiation Enteritis

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03

In context

Enteritis

34 studies on the registry are indexed under Enteritis; 7 are open to participants now.

This study's planned enrollment of 30 is below the median of 53 across 26 interventional studies indexed under Enteritis.

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Lead sponsor

Nanjing University School of Medicine is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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Inclusion criteria

  • Clinical diagnosis of chronic radiation enteritis
  • Need the operation
  • Malnutrition

Exclusion criteria

Exclusion Criteria:

  • Hepatic failure
  • Kidney failure
  • Neoplasm recurrence
  • Serious cardiovascular/metabolic disease
  • Pregnancy and lactation
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Placebo comparator
    placebo group

    Drug: Glutamine

  • Experimental
    Glutamine group

    Drug: Glutamine

Interventions

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

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What researchers measure

Primary outcomes

  1. inflammatory factor

    Time frame: 2 weeks after the surgery

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Study locations

1 site
  • Department of Surgery, Nanjing General Hospital of Nanjing Command
    Nanjing, Jiangsu 210002, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01758783
Lead sponsor
Nanjing University School of Medicine
Responsible party
Lei Zheng (Resident, Nanjing University School of Medicine) — Principal investigator
First posted
Jan 1, 2013
Start date
Jun 2012
Primary completion
Jun 2013 (estimated)
Completion
Jul 2013 (estimated)
Last update
Jan 4, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Glutamine

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