Ulcerative ColitisNCT00586807
Metabolic Response to Infliximab in Pediatric Ulcerative Colitis
A study testing Stable amino acid isotopes in people with Ulcerative Colitis and Protein Metabolism, run by Indiana University at 1 site in United States.
Trial summary
The metabolic response to ulcerative colitis, including increased proteolysis and lipolysis and changes in energy expenditure, plays a significant role in the resulting malnutrition from which these patients suffer. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Ulcerative Colitis, Protein Metabolism, Energy Expenditure
- What is being tested?
- Stable amino acid isotopes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Sep 2008
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female children between the ages of six and eighteen years of age
- Endoscopic or histologic evidence of ulcerative colitis
- Active ulcerative colitis determined by primary pediatric gastroenterologist to require anti-tumor necrosis factor-alpha antibody (infliximab) therapy
- Colitis symptom score ≥2
- Screening laboratory tests that meet the following criteria (obtained within 4 weeks of enrollment):
- Hemoglobin >8.0 g/dL
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- White blood cell count >3.5 x 109/L
- Neutrophils >1.5 x 109/L
- Platelets >100 x 109/L
- Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase levels within 3 times the upper limit of normal.
- PPD skin test with skin induration <5 mm.
- Signed written consent from the parent/legal guardian and assent from the child to be obtained prior to enrollment.
Who cannot join
- Female subjects who are pregnant, nursing, or planning pregnancy.
- Concomitant diagnosis or history of congestive heart failure.
- Serious infection in the 3 months prior to enrollment.
- History of prior or current active or latent tuberculosis.
- Immune deficiency syndrome, including documented human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- History of systemic lupus erythematosus.
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- A transplanted organ.
- Known malignancy or history of malignancy within 5 years of enrollment.
- History of demyelinating disease.
- History of substance abuse.
- History of diabetes mellitus.
- Poor tolerability of venipuncture or lack of venous access during the study period.
- A live virus vaccination within 3 months of enrollment.
- Prior history of infliximab infusion or any other therapeutic agent targeted at reducing tumor necrosis factor-alpha (TNF-alpha).
- Hypersensitivity to any murine proteins or other component of the product.
- Inability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University- Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
The metabolic response to ulcerative colitis, including increased proteolysis and lipolysis and changes in energy expenditure, plays a significant role in the resulting malnutrition from which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine, has been found to be elevated in children with ulcerative colitis. TNF-alpha has been incriminated in the mechanism of weight loss in many different chronic diseases, and causes net protein and lipid catabolism. Anti-TNF-alpha antibody (infliximab) has been proven to be an effective therapy for ulcerative colitis.
The purpose of this study is to determine changes in protein and lipid metabolism, as well as resting energy expenditure, before and after therapy with anti-TNF-alpha antibody (infliximab) in children with ulcerative colitis. Performing this study will better define the changes in nutrition status observed in these children following remission of active ulcerative colitis, and potentially lead to changes in medical and nutritional management of these children
- Conditions
- Ulcerative Colitis, Protein Metabolism, Energy Expenditure
- Being tested
- Stable amino acid isotopes
- Keywords
- Ulcerative colitis, pediatrics, UC, protein metabolism, energy expenditure
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable amino acid isotopesOther
Stable amino acid isotopes given per IV, dose based on weight and given over the length of the study visit.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | Other | Subjects on infliximab Receives: Other: Stable amino acid isotopes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure protein kinetics and balance in response to anti-TNF-alpha therapy in children with steroid-resistant ulcerative colitis, during both the fasting state and parenteral nutrition infusion.
Measured: Week 0 and 2
Secondary outcomes (1)
2. Measure energy expenditure by indirect calorimetry in response to anti-TNF-alpha therapy in children with steroid-resistant ulcerative colitis, during both the fasting state and parenteral nutrition infusion.
Measured: Week 0 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startJun 2005
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- ASPEN Rhoads Research Foundation
- Investigators
- Steven J Steiner, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586807
- Sponsor's protocol ID
- GCRC 1274
- Other IDs
- IRB #0503-23
- Status last verified
- Jan 2009
- First submitted
- 21 Dec 2007
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Response to Infliximab in Pediatric Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00586807
- Acronym / sponsor ID
- GCRC 1274
- Conditions
- Ulcerative Colitis, Protein Metabolism, Energy Expenditure
- Keywords
- Ulcerative colitis, pediatrics, UC, protein metabolism, energy expenditure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- ASPEN Rhoads Research Foundation
- Study start
- Jun 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 Jan 2008 (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.
The metabolic response to ulcerative colitis, including increased proteolysis and lipolysis and changes in energy expenditure, plays a significant role in the resulting malnutrition from which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine, has been found to be elevated in children with ulcerative colitis. TNF-alpha has been incriminated in the mechanism of weight loss in many different chronic diseases, and causes net protein and lipid catabolism. Anti-TNF-alpha antibody (infliximab) has been proven to be an effective therapy for ulcerative colitis.
The purpose of this study is to determine changes in protein and lipid metabolism, as well as resting energy expenditure, before and after therapy with anti-TNF-alpha antibody (infliximab) in children with ulcerative colitis. Performing this study will better define the changes in nutrition status observed in these children following remission of active ulcerative colitis, and potentially lead to changes in medical and nutritional management of these children
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infliximab | Other | Other: Stable amino acid isotopesSubjects on infliximab |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Male and female children between the ages of six and eighteen years of age
- Endoscopic or histologic evidence of ulcerative colitis
- Active ulcerative colitis determined by primary pediatric gastroenterologist to require anti-tumor necrosis factor-alpha antibody (infliximab) therapy
- Colitis symptom score ≥2
- Screening laboratory tests that meet the following criteria (obtained within 4 weeks of enrollment):
Key exclusion criteria (16 listed)
- Female subjects who are pregnant, nursing, or planning pregnancy.
- Concomitant diagnosis or history of congestive heart failure.
- Serious infection in the 3 months prior to enrollment.
- History of prior or current active or latent tuberculosis.
- Immune deficiency syndrome, including documented human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
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 |
|---|---|---|
| Stable amino acid isotopesStable amino acid isotopes given per IV, dose based on weight and given over the length of the study visit. | Other | Infliximab |
Primary outcome
Measure protein kinetics and balance in response to anti-TNF-alpha therapy in children with steroid-resistant ulcerative colitis, during both the fasting state and parenteral nutrition infusion.
Time frame: Week 0 and 2
1 secondary outcome
2. Measure energy expenditure by indirect calorimetry in response to anti-TNF-alpha therapy in children with steroid-resistant ulcerative colitis, during both the fasting state and parenteral nutrition infusion.
Time frame: Week 0 and 2
Results and safety
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
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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.
Steven J Steiner, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stable amino acid isotopes in people with Ulcerative Colitis and Protein Metabolism, run by Indiana University at 1 site in United States.
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 12 inclusion and 16 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: stopped early, as of the sponsor's last update on 30 Jan 2009. 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 United States. 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. 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?
The study was stopped early (reason given: poor enrollment). 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?
Measure protein kinetics and balance in response to anti-TNF-alpha therapy in children with steroid-resistant ulcerative colitis, during both the fasting state and parenteral nutrition infusion. (time frame: Week 0 and 2). 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 30 Jan 2009.