Inflammatory Bowel DiseaseNCT02330458
The Role of Small Bowel Ultrasound in Initiation of Infliximab in Crohn's Disease Patients
An observational study of Inflammatory Bowel Disease and Crohn's Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Goal is to prospectively determine if stool calprotectin and change in bowel wall thickness and hyperemia, as seen on small bowel ultrasound, at week 0, 14, and 54 can be used to predict response at week 54 to infliximab in pediatric patients with small bowel Crohn's Disease. Read more about this study
- Who is it for?
- Ages 6 to 23 years
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease
- What is being tested?
- Small bowel ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to May 2018
- Phase
- Observational
- 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 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with Crohn's disease involving the small bowel, initiating Infliximab treatment.
Who may be able to join
- Age 6-23 years
- Initiating Infliximab therapy
- Crohns disease involving the distal small bowel +/- proximal colon
- Willingness to undergo SBUS and fecal calprotectin collection prior to starting infliximab and again at week 14 and week 54
- Able to give consent by patient and/or legal guardian
Who cannot join
- Ulcerative colitis or non-Crohn's Disease patients
- Lack of small bowel disease
- Patients started on alternative therapy
- Unable or unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: The Role of Small Bowel Ultrasound After Ileocolic Resection or When Starting Infliximab in Crohn's Disease Patients
Goal is to prospectively determine if stool calprotectin and change in bowel wall thickness and hyperemia, as seen on small bowel ultrasound, at week 0, 14, and 54 can be used to predict response at week 54 to infliximab in pediatric patients with small bowel Crohn's Disease.
Read the detailed description
We will examine whether non-invasive disease monitoring tools such as bowel wall thickness as measured by small bowel ultrasound (SBUS) and mucosal inflammation as measured by fecal calprotectin, are independently associated with infliximab durability.
- Conditions
- Inflammatory Bowel Disease, Crohn's Disease
- Being tested
- Small bowel ultrasound
- Keywords
- Inflammatory Bowel Disease, Crohn's disease, Pediatric IBD, small bowel ultrasound, infliximab
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small bowel ultrasoundProcedure or surgery
Small Bowel Ultrasound will be performed by a single radiologist using an Acuson S2000 machine with 6 MHz convex and 9 MHz linear array transducers (Siemens, Germany). Participants will be asked to not eat for at least 8 hours prior to the ultrasound, and to drink 500ml of a fluid of their choice just prior to the SBUS, for bowel distension and better visualization. Bowel wall thickness (BWT), the length of any segment of thickened bowel wall >3mm, hyperemia using doppler, and the presence of free fluid, stricture, intestinal dilation, or enlarged lymph nodes will be documented
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bowel wall thickness on small bowel ultrasound (SBUS)
Change in bowel wall thickness as measured on small bowel ultrasound from ultrasound performed on week 0 to ultrasound performed at week 54. Small Bowel Ultrasound will be performed by a single radiologist using an Acuson S2000 machine with 6 MHz convex and 9 MHz linear array transducers (Siemens, Germany). Participants will be asked to not eat for at least 8 hours prior to the ultrasound, and to drink 500ml of a fluid of their choice just prior to the SBUS, for bowel distension and better visualization. Bowel wall thickness (BWT), the length of any segment of thickened bowel wall >3mm, hyperemia using doppler, and the presence of free fluid, stricture, intestinal dilation, or enlarged lymph nodes will be documented.
Univariate analyses will be performed to determine the association between bowel wall thickness on SBUS, and delta BWT (change in bowel wall thickness week 0 to week 14) and presence of remission at week 54
Measured: 1 year
Secondary outcomes (1)
Change in stool calprotectin
Change in level of stool calprotectin (lab) between week 0 and week 54. Stool will be collected within 24 hours of infusion and performed at our outpatient lab and analyzed by ELISA.
Univariate analyses will be performed to determine the association between calprotectin level, delta calprotectin level (change in calprotectin level week 0 to week 14) and presence of remission at week 54.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startJul 2014
- Primary completionMay 2017
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namita Singh, M.D., Cedars-Sinai Medical Center
- Investigators
- Namita Singh, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330458
- Sponsor's protocol ID
- Pro00027597
- Status last verified
- Jul 2017
- First submitted
- 31 Dec 2014
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Moscandrew ME, Loftus EV Jr. Diagnostic advances in inflammatory bowel disease (imaging and laboratory). Curr Gastroenterol Rep. 2009 Dec;11(6):488-95. doi: 10.1007/s11894-009-0074-7.
PubMed 19903425Strobel D, Goertz RS, Bernatik T. Diagnostics in inflammatory bowel disease: ultrasound. World J Gastroenterol. 2011 Jul 21;17(27):3192-7. doi: 10.3748/wjg.v17.i27.3192.
PubMed 21912467Allen PB, De Cruz P, Lee WK, Taylor S, Desmond PV, Kamm MA. Noninvasive imaging of the small bowel in Crohn's disease: the final frontier. Inflamm Bowel Dis. 2011 Sep;17(9):1987-99. doi: 10.1002/ibd.21598. Epub 2011 Feb 1.
PubMed 21287661Fraquelli M, Colli A, Casazza G, Paggi S, Colucci A, Massironi S, Duca P, Conte D. Role of US in detection of Crohn disease: meta-analysis. Radiology. 2005 Jul;236(1):95-101. doi: 10.1148/radiol.2361040799.
PubMed 15987966Parente F, Molteni M, Marino B, Colli A, Ardizzone S, Greco S, Sampietro G, Foschi D, Gallus S. Are colonoscopy and bowel ultrasound useful for assessing response to short-term therapy and predicting disease outcome of moderate-to-severe forms of ulcerative colitis?: a prospective study. Am J Gastroenterol. 2010 May;105(5):1150-7. doi: 10.1038/ajg.2009.672. Epub 2009 Dec 8.
PubMed 19997096
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Small Bowel Ultrasound After Ileocolic Resection or When Starting Infliximab in Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT02330458
- Acronym / sponsor ID
- Pro00027597
- Conditions
- Inflammatory Bowel Disease, Crohn's Disease
- Keywords
- Inflammatory Bowel Disease, Crohn's disease, Pediatric IBD, small bowel ultrasound, infliximab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2018 (estimated)
- First posted
- 5 Jan 2015 (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.
Goal is to prospectively determine if stool calprotectin and change in bowel wall thickness and hyperemia, as seen on small bowel ultrasound, at week 0, 14, and 54 can be used to predict response at week 54 to infliximab in pediatric patients with small bowel Crohn's Disease.
Detailed description
We will examine whether non-invasive disease monitoring tools such as bowel wall thickness as measured by small bowel ultrasound (SBUS) and mucosal inflammation as measured by fecal calprotectin, are independently associated with infliximab durability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with Crohn's disease involving the small bowel, initiating Infliximab treatment.
Key inclusion criteria (5 listed)
- Age 6-23 years
- Initiating Infliximab therapy
- Crohns disease involving the distal small bowel +/- proximal colon
- Willingness to undergo SBUS and fecal calprotectin collection prior to starting infliximab and again at week 14 and week 54
- Able to give consent by patient and/or legal guardian
Key exclusion criteria (4 listed)
- Ulcerative colitis or non-Crohn's Disease patients
- Lack of small bowel disease
- Patients started on alternative therapy
- Unable or unwilling to provide consent
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 |
|---|---|---|
| Small bowel ultrasoundSmall Bowel Ultrasound will be performed by a single radiologist using an Acuson S2000 machine with 6 MHz convex and 9 MHz linear array transducers (Siemens, Germany). Participants will be asked to not eat for at least 8 hours prior to the ultrasound, and to drink 500ml of a fluid of their choice just prior to the SBUS, for bowel distension and better visualization. Bowel wall thickness (BWT), the length of any segment of thickened bowel wall >3mm, hyperemia using doppler, and the presence of free fluid, stricture, intestinal dilation, or enlarged lymph nodes will be documented | Procedure or surgery | – |
Primary outcome
Change in bowel wall thickness on small bowel ultrasound (SBUS)
Time frame: 1 year
Change in bowel wall thickness as measured on small bowel ultrasound from ultrasound performed on week 0 to ultrasound performed at week 54. Small Bowel Ultrasound will be performed by a single radiologist using an Acuson S2000 machine with 6 MHz convex and 9 MHz linear array transducers (Siemens, Germany). Participants will be asked to not eat for at least 8 hours prior to the ultrasound, and to drink 500ml of a fluid of their choice just prior to the SBUS, for bowel distension and better visualization. Bowel wall thickness (BWT), the length of any segment of thickened bowel wall >3mm, hyperemia using doppler, and the presence of free fluid, stricture, intestinal dilation, or enlarged lymph nodes will be documented. Univariate analyses will be performed to determine the association between bowel wall thickness on SBUS, and delta BWT (change in bowel wall thickness week 0 to week 14) and presence of remission at week 54
1 secondary outcome
Change in stool calprotectin
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Background: PubMed 19903425Moscandrew ME, Loftus EV Jr. Diagnostic advances in inflammatory bowel disease (imaging and laboratory). Curr Gastroenterol Rep. 2009 Dec;11(6):488-95. doi: 10.1007/s11894-009-0074-7.
- Background: PubMed 21912467Strobel D, Goertz RS, Bernatik T. Diagnostics in inflammatory bowel disease: ultrasound. World J Gastroenterol. 2011 Jul 21;17(27):3192-7. doi: 10.3748/wjg.v17.i27.3192.
- Background: PubMed 21287661Allen PB, De Cruz P, Lee WK, Taylor S, Desmond PV, Kamm MA. Noninvasive imaging of the small bowel in Crohn's disease: the final frontier. Inflamm Bowel Dis. 2011 Sep;17(9):1987-99. doi: 10.1002/ibd.21598. Epub 2011 Feb 1.
- Background: PubMed 15987966Fraquelli M, Colli A, Casazza G, Paggi S, Colucci A, Massironi S, Duca P, Conte D. Role of US in detection of Crohn disease: meta-analysis. Radiology. 2005 Jul;236(1):95-101. doi: 10.1148/radiol.2361040799.
- Background: PubMed 19997096Parente F, Molteni M, Marino B, Colli A, Ardizzone S, Greco S, Sampietro G, Foschi D, Gallus S. Are colonoscopy and bowel ultrasound useful for assessing response to short-term therapy and predicting disease outcome of moderate-to-severe forms of ulcerative colitis?: a prospective study. Am J Gastroenterol. 2010 May;105(5):1150-7. doi: 10.1038/ajg.2009.672. Epub 2009 Dec 8.
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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.
Namita Singh, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Crohn's Disease, run by Cedars-Sinai Medical Center 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 5 inclusion and 4 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 19 Jul 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.
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?
Change in bowel wall thickness on small bowel ultrasound (SBUS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02330458, which also lists 5 linked publications.
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 19 Jul 2017.