Radiation EnteritisNCT01758783
Therapy of Radiation Enteritis With Glutamine
A study testing Glutamine in people with Radiation Enteritis, run by Nanjing University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Radiation Enteritis
- What is being tested?
- Glutamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of chronic radiation enteritis
- Need the operation
- Malnutrition
Who cannot join
- Hepatic failure
- Kidney failure
- Neoplasm recurrence
- Serious cardiovascular/metabolic disease
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Surgery, Nanjing General Hospital of Nanjing Command
Nanjing, Jiangsu, 210002
About this study
Official title: the Efficacy of Glutamine in the Therapy of Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
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.
- Conditions
- Radiation Enteritis
- Being tested
- Glutamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDrug
amino acid：1.2-2g/(kg·d) Glutamine：0.5g /(kg·d)
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | Not described Receives: Drug: Glutamine |
| Glutamine group | Experimental | Not described Receives: Drug: Glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory factor
Measured: 2 weeks after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation EnteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Zheng, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758783
- Sponsor's protocol ID
- Radiation Enteritis 001
- Status last verified
- Jan 2013
- First submitted
- 27 Dec 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Efficacy of Glutamine in the Therapy of Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
- ClinicalTrials.gov ID
- NCT01758783
- Acronym / sponsor ID
- Radiation Enteritis 001
- Conditions
- Radiation Enteritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: Glutamine |
| Glutamine group | Experimental | Drug: Glutamine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of chronic radiation enteritis
- Need the operation
- Malnutrition
Key exclusion criteria (5 listed)
- Hepatic failure
- Kidney failure
- Neoplasm recurrence
- Serious cardiovascular/metabolic disease
- Pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glutamineamino acid：1.2-2g/(kg·d) Glutamine：0.5g /(kg·d) | Drug | Glutamine group, placebo group |
Primary outcome
inflammatory factor
Time frame: 2 weeks after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutamine in people with Radiation Enteritis, run by Nanjing University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory factor (time frame: 2 weeks after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.