Crohn's DiseaseNCT00586352
Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease
A study testing stable isotope infusions in people with Crohn's Disease and Ulcerative Colitis, run by Indiana University at 1 site in United States.
Trial summary
Inflammatory bowel disease, which includes both Crohn's disease and ulcerative colitis, is a disease of the gastrointestinal tract leading to symptoms of abdominal pain, diarrhea, and growth disturbance. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Protein 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
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Nov 2011
- 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
- Suspected inflammatory bowel disease or chronic abdominal pain not suspected of having inflammatory bowel disease
- 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
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- Platelets >100 x 109/L
- Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase levels within 3 times the upper limit of normal.
- Parent or guardian signing witnessed, informed consent
- Child (if > age 7) signing assent
Who cannot join
- Known malignancy or history of malignancy within 5 years of enrollment.
- Positive stool examination for enteric pathogens including Salmonella and Shigella species, Clostridium difficile, and Giardia lamblia.
- Female subjects who are pregnant, nursing, or planning pregnancy.
- History of substance abuse.
- Poor tolerability of venipuncture or lack of venous access during the study period.
- 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
Inflammatory bowel disease, which includes both Crohn's disease and ulcerative colitis, is a disease of the gastrointestinal tract leading to symptoms of abdominal pain, diarrhea, and growth disturbance. Crohn's disease is a chronic inflammatory process that may affect any part of the gastrointestinal tract, whereas ulcerative colitis is typically present only in the colon. Children with inflammatory bowel disease frequently suffer from disturbances in growth, which may continue into adulthood and result in altered growth outcomes. The metabolic response to inflammatory bowel disease, including increased protein breakdown and decreased protein synthesis may play a significant role in the resulting malnutrition and growth failure from which children with inflammatory bowel disease suffer. The purpose of this study is to compare the rates of protein synthesis within the mucosal lining of the gastrointestinal tract in children Crohn's disease or ulcerative colitis to children who have normal endoscopic examinations. By comparing children with inflammatory bowel disease to normal children, we can begin to determine how alterations in protein metabolism within the lining of the gastrointestinal tract affect whole body protein metabolism, and its consequent effects on growth. In those patients diagnosed with Crohn's disease or ulcerative colitis, a follow-up study will be conducted two weeks following the initiation of steroid therapy to determine its effects on protein metabolism. We hypothesize that children with active inflammatory bowel disease will have increased rates of protein synthesis in the lining of the gastrointestinal tract than patients who have normal endoscopy, and that increases in protein breakdown and protein synthesis will be improved following steroid therapy in children with newly diagnosed inflammatory bowel disease.
- Conditions
- Crohn's Disease, Ulcerative Colitis, Protein Metabolism
- Being tested
- stable isotope infusions
- Keywords
- Pediatric, Crohn's disease, Ulcerative colitis
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stable isotope infusionsOther
Subjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight.
| Study group | Role | What they receive |
|---|---|---|
| Normal | Active comparator | Subjects who have normal endoscopic findings Receives: Other: stable isotope infusions |
| Newly diagnosed Crohn's disease | Active comparator | Subjects who are newly diagnosed with Crohn's disease after endoscopy. Receives: Other: stable isotope infusions |
| Newly diagnosed Ulcerative Colitis | Active comparator | Subjects diagnosed with Ulcerative Colitis after endoscopy Receives: Other: stable isotope infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare gastrointestinal mucosal protein synthesis rates among children with newly diagnosed Crohn's disease and ulcerative colitis to children with normal endoscopic findings.
Measured: Week 0
Secondary outcomes (1)
Compare whole body protein metabolism in children with newly diagnosed Crohn's disease and ulcerative colitis before and 2 weeks after initiation of corticosteroid therapy.
Measured: Week 0 and Week 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 startJan 2006
- Primary completionNov 2011
- Study completionNov 2011
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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health
- Responsible party
- Sponsor
- Investigators
- Steven J Steiner, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586352
- Sponsor's protocol ID
- GCRC 1351
- Other IDs
- IRB 0512-16
- Status last verified
- Jul 2016
- First submitted
- 21 Dec 2007
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Metabolism in Newly Diagnosed Pediatric Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00586352
- Acronym / sponsor ID
- GCRC 1351
- Conditions
- Crohn's Disease, Ulcerative Colitis, Protein Metabolism
- Keywords
- Pediatric, Crohn's disease, Ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health
- Study start
- Jan 2006
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (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.
Inflammatory bowel disease, which includes both Crohn's disease and ulcerative colitis, is a disease of the gastrointestinal tract leading to symptoms of abdominal pain, diarrhea, and growth disturbance. Crohn's disease is a chronic inflammatory process that may affect any part of the gastrointestinal tract, whereas ulcerative colitis is typically present only in the colon. Children with inflammatory bowel disease frequently suffer from disturbances in growth, which may continue into adulthood and result in altered growth outcomes. The metabolic response to inflammatory bowel disease, including increased protein breakdown and decreased protein synthesis may play a significant role in the resulting malnutrition and growth failure from which children with inflammatory bowel disease suffer. The purpose of this study is to compare the rates of protein synthesis within the mucosal lining of the gastrointestinal tract in children Crohn's disease or ulcerative colitis to children who have normal endoscopic examinations. By comparing children with inflammatory bowel disease to normal children, we can begin to determine how alterations in protein metabolism within the lining of the gastrointestinal tract affect whole body protein metabolism, and its consequent effects on growth. In those patients diagnosed with Crohn's disease or ulcerative colitis, a follow-up study will be conducted two weeks following the initiation of steroid therapy to determine its effects on protein metabolism. We hypothesize that children with active inflammatory bowel disease will have increased rates of protein synthesis in the lining of the gastrointestinal tract than patients who have normal endoscopy, and that increases in protein breakdown and protein synthesis will be improved following steroid therapy in children with newly diagnosed inflammatory bowel disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | Active comparator | Other: stable isotope infusionsSubjects who have normal endoscopic findings |
| Newly diagnosed Crohn's disease | Active comparator | Other: stable isotope infusionsSubjects who are newly diagnosed with Crohn's disease after endoscopy. |
| Newly diagnosed Ulcerative Colitis | Active comparator | Other: stable isotope infusionsSubjects diagnosed with Ulcerative Colitis after endoscopy |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Male and female children between the ages of six and eighteen years of age
- Suspected inflammatory bowel disease or chronic abdominal pain not suspected of having inflammatory bowel disease
- Screening laboratory tests that meet the following criteria (obtained within 4 weeks of enrollment):
- Parent or guardian signing witnessed, informed consent
- Child (if > age 7) signing assent
Key exclusion criteria (6 listed)
- Known malignancy or history of malignancy within 5 years of enrollment.
- Positive stool examination for enteric pathogens including Salmonella and Shigella species, Clostridium difficile, and Giardia lamblia.
- Female subjects who are pregnant, nursing, or planning pregnancy.
- History of substance abuse.
- Poor tolerability of venipuncture or lack of venous access during the study period.
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 infusionsSubjects receive stable isotope infusions through an IV for about 3 hours. The dosage is based on weight. | Other | Newly diagnosed Crohn's disease, Newly diagnosed Ulcerative Colitis, Normal |
Primary outcome
Compare gastrointestinal mucosal protein synthesis rates among children with newly diagnosed Crohn's disease and ulcerative colitis to children with normal endoscopic findings.
Time frame: Week 0
1 secondary outcome
Compare whole body protein metabolism in children with newly diagnosed Crohn's disease and ulcerative colitis before and 2 weeks after initiation of corticosteroid therapy.
Time frame: Week 0 and Week 2
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 2 Aug 2016.
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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 isotope infusions in people with Crohn's Disease and Ulcerative Colitis, 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 10 inclusion and 6 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 2 Aug 2016. 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 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 gastrointestinal mucosal protein synthesis rates among children with newly diagnosed Crohn's disease and ulcerative colitis to children with normal endoscopic findings. (time frame: Week 0). 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 2 Aug 2016.