Crohn's DiseasePhase 1NCT00583232
Protein and Energy Metabolism in Pediatric Crohn's Disease
A Phase 1 study testing Stable isotope infusions in people with Crohn's Disease and Protein Metabolism, run by Indiana University at 1 site in United States.
Trial summary
The metabolic response to Crohn's disease, 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
- Crohn's Disease, Protein Metabolism, Energy Metabolism
- What is being tested?
- Stable isotope infusions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Dec 2008
- Phase
- Phase 1
- 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 with recurrence of active Crohn's disease, determined by their primary pediatric gastroenterologist to require either:
- Corticosteroid therapy ((1-2 mg/kg/d up to maximum of 60 mg/day) with taper, or
- Infliximab therapy (5 mg/kg at 0, 2, and 6 weeks, followed by q 8 week therapy)
- Crohn's disease of at least 3 months since diagnosis, with gastritis, duodenitis, ileitis, ileocolitis, or colitis, confirmed by endoscopy and biopsy
- PCDAI score >20
- If receiving concomitant medications, must have been on a stable regimen as follows:
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- Subjects on aminosalicylates and/or immunomodulators should be on a stable dose for at least 2 weeks prior to enrollment.
- Subjects must be off oral, rectal, and parenteral corticosteroids at least 2 weeks prior to enrollment.
- Screening laboratory tests that meet the following criteria (obtained within 4 weeks of enrollment):
- Hemoglobin >8.0 g/dL
- 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.
- For those patients to receive infliximab, PPD skin tests 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
- Local manifestations of Crohn's disease, including fistula(s), strictures, abscesses, or other complications for which surgery may be indicated.
- Surgery for bowel diversion with placement of stoma within 3 months prior to screening.
- Positive stool examination of enteric pathogens including Salmonella and Shigella species, Clostridium difficile, and Giardia lamblia.
- Female subjects who are pregnant, nursing, or planning pregnancy.
- Concomitant diagnosis or history of congestive heart failure.
- Treatment with parenteral nutrition within 4 weeks of enrollment.
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- 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.
- A transplanted organ.
- Known malignancy or history of malignancy within 5 years of enrollment.
- History of demyelinating disease.
- History of substance abuse.
- 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-a (TNF-a).
- Hypersensitivity to any murine proteins or other component of infliximab for those patients to receive infliximab.
- 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 Crohn's disease, 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 compare changes in protein and lipid metabolism, as well as resting energy expenditure, before and after therapy with anti-TNF-alpha antibody (infliximab) or corticosteroids in children with recurrent Crohn's disease. Performing this study will better define the changes in nutrition status observed in these children following remission of active Crohn's disease, and potentially lead to changes in medical and nutritional management of these children.
- Conditions
- Crohn's Disease, Protein Metabolism, Energy Metabolism
- Being tested
- Stable isotope infusions
- Keywords
- Pediatric, Crohn's disease, protein metabolism, energy metabolism
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable isotope infusionsDrug
Stable isotope infusion will be given via an intravenous catheter. Subjects will receive a priming dose and a continuous dose.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid | Active comparator | Subjects receiving corticosteroid therapy (1-2 mg/kg/day up to 60mg/day) with taper. Receives: Drug: Stable isotope infusions |
| infliximab | Active comparator | Subjects receiving infliximab therapy (5 mg/kg at 0, 2 and 6 weeks, followed by every 8 week therapy) Receives: Drug: Stable isotope infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare whole body and splanchnic protein kinetics and balance in response to corticosteroid and anti-TNF-alpha therapies in the fasting state and during enteral nutrition infusion.
Measured: Week 0, 2 and 14
Secondary outcomes (7)
Compare the effects of corticosteroid and anti-TNF-alpha therapies on resting and total energy expenditure.
Measured: Week 0, 2 and 14
Compare the effects of corticosteroid and anti-TNF-alpha therapies on free fatty acid metabolism
Measured: Week 0, 2 and 14
Compare the effects of corticosteroid and anti-TNF-alpha therapies on quality of life
Measured: Week 0, 2, and 14
Comparing the effects of corticosteroid and anti-TNF-alpha therapies on bone turnover and bone density
Measured: Week 0,2 and 14
Compare the effects of corticosteroid and anti-TNF-alpha therapies on body composition.
Measured: Week 0, 2 and 14
Compare the effects of corticosteroid and anti-TNF-alpha therapies on cytokines known to be altered in inflammatory bowel disease.
Measured: Week 0, 2 and 14
Compare the effects of corticosteroid and anti-TNF-alpha therapies on vascular endothelial function.
Measured: Week 0, 2 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startFeb 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Crohn's and Colitis Foundation, National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Steven J. Steiner, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583232
- Sponsor's protocol ID
- 0506-19
- Other IDs
- IRB 0506-19
- Status last verified
- Mar 2017
- First submitted
- 20 Dec 2007
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein and Energy Metabolism in Pediatric Crohn's Disease
- ClinicalTrials.gov ID
- NCT00583232
- Acronym / sponsor ID
- 0506-19
- Conditions
- Crohn's Disease, Protein Metabolism, Energy Metabolism
- Keywords
- Pediatric, Crohn's disease, protein metabolism, energy metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Crohn's and Colitis Foundation, National Center for Research Resources (NCRR)
- Study start
- Feb 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 31 Dec 2007 (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 Crohn's disease, 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 compare changes in protein and lipid metabolism, as well as resting energy expenditure, before and after therapy with anti-TNF-alpha antibody (infliximab) or corticosteroids in children with recurrent Crohn's disease. Performing this study will better define the changes in nutrition status observed in these children following remission of active Crohn's disease, and potentially lead to changes in medical and nutritional management of these children.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid | Active comparator | Drug: Stable isotope infusionsSubjects receiving corticosteroid therapy (1-2 mg/kg/day up to 60mg/day) with taper. |
| infliximab | Active comparator | Drug: Stable isotope infusionsSubjects receiving infliximab therapy (5 mg/kg at 0, 2 and 6 weeks, followed by every 8 week therapy) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Male and female children between the ages of six and eighteen years of age with recurrence of active Crohn's disease, determined by their primary pediatric gastroenterologist to require either:
- Crohn's disease of at least 3 months since diagnosis, with gastritis, duodenitis, ileitis, ileocolitis, or colitis, confirmed by endoscopy and biopsy
- PCDAI score >20
- If receiving concomitant medications, must have been on a stable regimen as follows:
- Screening laboratory tests that meet the following criteria (obtained within 4 weeks of enrollment):
Key exclusion criteria (19 listed)
- Local manifestations of Crohn's disease, including fistula(s), strictures, abscesses, or other complications for which surgery may be indicated.
- Surgery for bowel diversion with placement of stoma within 3 months prior to screening.
- Positive stool examination of enteric pathogens including Salmonella and Shigella species, Clostridium difficile, and Giardia lamblia.
- Female subjects who are pregnant, nursing, or planning pregnancy.
- Concomitant diagnosis or history of congestive heart failure.
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 isotope infusionsStable isotope infusion will be given via an intravenous catheter. Subjects will receive a priming dose and a continuous dose. | Drug | Corticosteroid, infliximab |
Primary outcome
Compare whole body and splanchnic protein kinetics and balance in response to corticosteroid and anti-TNF-alpha therapies in the fasting state and during enteral nutrition infusion.
Time frame: Week 0, 2 and 14
7 secondary outcomes
Compare the effects of corticosteroid and anti-TNF-alpha therapies on resting and total energy expenditure.
Time frame: Week 0, 2 and 14
Compare the effects of corticosteroid and anti-TNF-alpha therapies on free fatty acid metabolism
Time frame: Week 0, 2 and 14
Compare the effects of corticosteroid and anti-TNF-alpha therapies on quality of life
Time frame: Week 0, 2, and 14
Comparing the effects of corticosteroid and anti-TNF-alpha therapies on bone turnover and bone density
Time frame: Week 0,2 and 14
Compare the effects of corticosteroid and anti-TNF-alpha therapies on body composition.
Time frame: Week 0, 2 and 14
Compare the effects of corticosteroid and anti-TNF-alpha therapies on cytokines known to be altered in inflammatory bowel disease.
Time frame: Week 0, 2 and 14
Compare the effects of corticosteroid and anti-TNF-alpha therapies on vascular endothelial function.
Time frame: Week 0, 2 and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
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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 Phase 1 study testing Stable isotope infusions in people with Crohn's Disease 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 16 inclusion and 19 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: finished, as of the sponsor's last update on 16 Mar 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare whole body and splanchnic protein kinetics and balance in response to corticosteroid and anti-TNF-alpha therapies in the fasting state and during enteral nutrition infusion. (time frame: Week 0, 2 and 14). 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 16 Mar 2017.