Inflammatory Bowel DiseasesPhase 4NCT02946203
Comparison of VoLumen and Breeza Oral Contrast Agents in Pediatric Patients
A Phase 4 study testing Barium Sulfate and Flavored beverage Oral Contrast in people with Inflammatory Bowel Diseases, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
In this research study, two different oral contrast materials that can be used for CT or MR enterography will be studied. This study is designed to compare which oral contrast material (VoLumen or Breeza) is preferred by pediatric patients and which provides higher quality exams. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Barium Sulfate and Flavored beverage Oral Contrast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Nov 2017
- Phase
- Phase 4
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age > 8 years and < 18 years
- Patients undergoing clinically indicated CT or MR enterography
Who cannot join
- Age < 8 years and ≥ 18 years
- Requirement for sedation for CT or MRI enterography
- Cannot drink oral contrast (will require tube administration)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Prospective Comparison of VoLumen and Breeza Oral Contrast Agents in Pediatric Patients Undergoing CT and MR Enterography
In this research study, two different oral contrast materials that can be used for CT or MR enterography will be studied. This study is designed to compare which oral contrast material (VoLumen or Breeza) is preferred by pediatric patients and which provides higher quality exams.
Read the detailed description
VoLumen, a low Hounsfield unit 0.1% barium sulfate suspension that also contains sorbitol and a gum, is the most common oral contrast material used in children and adults undergoing CT and MR enterography (advanced imaging tests used to evaluate the bowel lumen and bowel wall in children and adults, usually with suspected or known Crohn disease). This contrast material is typically administered orally to non-sedated patients during the 45-60 minute period prior to imaging. The goal of oral contrast material administration is to completely fill the small bowel with fluid at the time of imaging. Benefits of oral contrast material at cross-sectional enterography include: improved delineation of bowel from non-bowel structures in the abdomen and pelvis, improved accuracy when assessing bowel wall thickness, and improved visualization of mucosal hyper-enhancement in the setting of active intestinal inflammation.
In some children (and adults), the standard-of-care contrast agent (VoLumen) is poorly tolerated. This is likely due to a variety of factors, including taste, texture, and the volume that is required to be consumed. Recently, a new oral contrast material called "Breeza for neutral abdominopelvic imaging" (or simply Breeza) has become available for use at CT and MR enterography. This agent contains sorbitol, mannitol, and xantham gum (a thickening agent), and it is marketed as a "flavored beverage" as it contains no active ingredient (e.g., barium sulfate). A single study performed in adult volunteers has shown that this new agent performs similar to VoLumen, has a superior taste, and is associated with greater willingness for repeat drinking.
The objective of our study is to compare our standard-of-care oral contrast material to the newly available contrast material in a prospective, randomized, blinded manner. Primary outcomes will include degree of small bowel opacification, distention of the terminal ileum, and patient acceptance/tolerability.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Barium Sulfate, Flavored beverage Oral Contrast
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barium SulfateOther
Also called VoLumen
Barium Sulfate Oral Contrast-VoLumen
Flavored beverage Oral ContrastOther
Also called Breeza
Flavored beverage for neutral abdominal/pelvic imaging
| Study group | Role | What they receive |
|---|---|---|
| Flavored Beverage Oral Contrast-Breeza | Active comparator | Pediatric patients that are undergoing awake CT and MR enterography at the Cincinnati Children's Hospital Medical Center (CCHMC) base (Burnett) campus will be randomized to either VoLumen (current standard of care oral contrast) or Breeza. Receives: Other: Flavored beverage Oral Contrast |
| Barium Sulfate Oral Contrast-VoLumen | Active comparator | Pediatric patients that are undergoing awake CT and MR enterography at the CCHMC base (Burnett) campus will be randomized to either VoLumen (current standard of care oral contrast) or Breeza. Receives: Other: Barium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of bowel opacification as determined by estimated percentage of overall small bowel opacification
To compare the degree of bowel opacification provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography. The degree of bowel opacification will be rated 0-100 percent.
Measured: 1 year
Degree of bowel opacification, rated subjectively as excellent, diagnostic, suboptimal or poor
To compare the degree of bowel opacification provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography.
Measured: 1 year
Degree of bowel distention as determined by measurement of the largest diameter, normal, small bowel loop in each of the four abdominal quadrants
To compare the degree of bowel distention, measured in millimeters, provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography
Measured: 1 year
Degree of bowel distention rated subjectively as excellent, diagnostic, suboptimal or poor
To compare the degree of bowel distention provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography
Measured: 1 year
Secondary outcomes (2)
Tolerability as assessed by patient survey with respect to overall tolerability, taste and texture
To compare the patient tolerability of Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography as assessed by patient survey using the Likert scale rating of 0-10
Measured: 1 year
Tolerability as assessed by patient survey with respect to abdominal symptoms as well as overall state of well-being
To compare the patient tolerability of Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography as assesses by patient survey using the Likert scale rating of 0-10
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 posted27 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Dillman, MD, MSc, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946203
- Sponsor's protocol ID
- CIN_Breeza_001
- Status last verified
- Feb 2018
- First submitted
- 4 Oct 2016
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dillman JR, Adler J, Zimmermann EM, Strouse PJ. CT enterography of pediatric Crohn disease. Pediatr Radiol. 2010 Jan;40(1):97-105. doi: 10.1007/s00247-009-1465-5. Epub 2009 Nov 20.
PubMed 19936733Mollard BJ, Smith EA, Dillman JR. Pediatric MR enterography: technique and approach to interpretation-how we do it. Radiology. 2015 Jan;274(1):29-43. doi: 10.1148/radiol.14122449.
PubMed 25531478Towbin AJ, Sullivan J, Denson LA, Wallihan DB, Podberesky DJ. CT and MR enterography in children and adolescents with inflammatory bowel disease. Radiographics. 2013 Nov-Dec;33(7):1843-60. doi: 10.1148/rg.337105140.
PubMed 24224581Young BM, Fletcher JG, Booya F, Paulsen S, Fidler J, Johnson CD, Huprich J, Barlow J, Trout A. Head-to-head comparison of oral contrast agents for cross-sectional enterography: small bowel distention, timing, and side effects. J Comput Assist Tomogr. 2008 Jan-Feb;32(1):32-8. doi: 10.1097/RCT.0b013e318061961d.
PubMed 18303285Absah I, Bruining DH, Matsumoto JM, Weisbrod AJ, Fletcher JG, Fidler JL, Faubion WA Jr. MR enterography in pediatric inflammatory bowel disease: retrospective assessment of patient tolerance, image quality, and initial performance estimates. AJR Am J Roentgenol. 2012 Sep;199(3):W367-75. doi: 10.2214/AJR.11.8363.
PubMed 22915428Kolbe AB, Fletcher JG, Froemming AT, Sheedy SP, Koo CW, Pundi K, Bruining DH, Tung J, Harmsen WS, Barlow JM, Fidler JL. Evaluation of Patient Tolerance and Small-Bowel Distention With a New Small-Bowel Distending Agent for Enterography. AJR Am J Roentgenol. 2016 May;206(5):994-1002. doi: 10.2214/AJR.15.15260. Epub 2016 Mar 21.
PubMed 26998661
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of VoLumen and Breeza Oral Contrast Agents in Pediatric Patients Undergoing CT and MR Enterography
- ClinicalTrials.gov ID
- NCT02946203
- Acronym / sponsor ID
- CIN_Breeza_001
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 27 Oct 2016 (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.
In this research study, two different oral contrast materials that can be used for CT or MR enterography will be studied. This study is designed to compare which oral contrast material (VoLumen or Breeza) is preferred by pediatric patients and which provides higher quality exams.
Detailed description
VoLumen, a low Hounsfield unit 0.1% barium sulfate suspension that also contains sorbitol and a gum, is the most common oral contrast material used in children and adults undergoing CT and MR enterography (advanced imaging tests used to evaluate the bowel lumen and bowel wall in children and adults, usually with suspected or known Crohn disease). This contrast material is typically administered orally to non-sedated patients during the 45-60 minute period prior to imaging. The goal of oral contrast material administration is to completely fill the small bowel with fluid at the time of imaging. Benefits of oral contrast material at cross-sectional enterography include: improved delineation of bowel from non-bowel structures in the abdomen and pelvis, improved accuracy when assessing bowel wall thickness, and improved visualization of mucosal hyper-enhancement in the setting of active intestinal inflammation.
In some children (and adults), the standard-of-care contrast agent (VoLumen) is poorly tolerated. This is likely due to a variety of factors, including taste, texture, and the volume that is required to be consumed. Recently, a new oral contrast material called "Breeza for neutral abdominopelvic imaging" (or simply Breeza) has become available for use at CT and MR enterography. This agent contains sorbitol, mannitol, and xantham gum (a thickening agent), and it is marketed as a "flavored beverage" as it contains no active ingredient (e.g., barium sulfate). A single study performed in adult volunteers has shown that this new agent performs similar to VoLumen, has a superior taste, and is associated with greater willingness for repeat drinking.
The objective of our study is to compare our standard-of-care oral contrast material to the newly available contrast material in a prospective, randomized, blinded manner. Primary outcomes will include degree of small bowel opacification, distention of the terminal ileum, and patient acceptance/tolerability.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flavored Beverage Oral Contrast-Breeza | Active comparator | Other: Flavored beverage Oral ContrastPediatric patients that are undergoing awake CT and MR enterography at the Cincinnati Children's Hospital Medical Center (CCHMC) base (Burnett) campus will be randomized to either VoLumen (current standard of care oral contrast) or Breeza. |
| Barium Sulfate Oral Contrast-VoLumen | Active comparator | Other: Barium SulfatePediatric patients that are undergoing awake CT and MR enterography at the CCHMC base (Burnett) campus will be randomized to either VoLumen (current standard of care oral contrast) or Breeza. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age > 8 years and < 18 years
- Patients undergoing clinically indicated CT or MR enterography
Key exclusion criteria (3 listed)
- Age < 8 years and ≥ 18 years
- Requirement for sedation for CT or MRI enterography
- Cannot drink oral contrast (will require tube administration)
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 |
|---|---|---|
| Barium SulfateAlso: VoLumenBarium Sulfate Oral Contrast-VoLumen | Other | Barium Sulfate Oral Contrast-VoLumen |
| Flavored beverage Oral ContrastAlso: BreezaFlavored beverage for neutral abdominal/pelvic imaging | Other | Flavored Beverage Oral Contrast-Breeza |
Primary outcome
Degree of bowel opacification as determined by estimated percentage of overall small bowel opacification
Time frame: 1 year
To compare the degree of bowel opacification provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography. The degree of bowel opacification will be rated 0-100 percent.
Degree of bowel opacification, rated subjectively as excellent, diagnostic, suboptimal or poor
Time frame: 1 year
To compare the degree of bowel opacification provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography.
Degree of bowel distention as determined by measurement of the largest diameter, normal, small bowel loop in each of the four abdominal quadrants
Time frame: 1 year
To compare the degree of bowel distention, measured in millimeters, provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography
Degree of bowel distention rated subjectively as excellent, diagnostic, suboptimal or poor
Time frame: 1 year
To compare the degree of bowel distention provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography
2 secondary outcomes
Tolerability as assessed by patient survey with respect to overall tolerability, taste and texture
Time frame: 1 year
Tolerability as assessed by patient survey with respect to abdominal symptoms as well as overall state of well-being
Time frame: 1 year
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 13 Feb 2018.
- Background: PubMed 19936733Dillman JR, Adler J, Zimmermann EM, Strouse PJ. CT enterography of pediatric Crohn disease. Pediatr Radiol. 2010 Jan;40(1):97-105. doi: 10.1007/s00247-009-1465-5. Epub 2009 Nov 20.
- Background: PubMed 25531478Mollard BJ, Smith EA, Dillman JR. Pediatric MR enterography: technique and approach to interpretation-how we do it. Radiology. 2015 Jan;274(1):29-43. doi: 10.1148/radiol.14122449.
- Background: PubMed 24224581Towbin AJ, Sullivan J, Denson LA, Wallihan DB, Podberesky DJ. CT and MR enterography in children and adolescents with inflammatory bowel disease. Radiographics. 2013 Nov-Dec;33(7):1843-60. doi: 10.1148/rg.337105140.
- Background: PubMed 18303285Young BM, Fletcher JG, Booya F, Paulsen S, Fidler J, Johnson CD, Huprich J, Barlow J, Trout A. Head-to-head comparison of oral contrast agents for cross-sectional enterography: small bowel distention, timing, and side effects. J Comput Assist Tomogr. 2008 Jan-Feb;32(1):32-8. doi: 10.1097/RCT.0b013e318061961d.
- Background: PubMed 22915428Absah I, Bruining DH, Matsumoto JM, Weisbrod AJ, Fletcher JG, Fidler JL, Faubion WA Jr. MR enterography in pediatric inflammatory bowel disease: retrospective assessment of patient tolerance, image quality, and initial performance estimates. AJR Am J Roentgenol. 2012 Sep;199(3):W367-75. doi: 10.2214/AJR.11.8363.
- Background: PubMed 26998661Kolbe AB, Fletcher JG, Froemming AT, Sheedy SP, Koo CW, Pundi K, Bruining DH, Tung J, Harmsen WS, Barlow JM, Fidler JL. Evaluation of Patient Tolerance and Small-Bowel Distention With a New Small-Bowel Distending Agent for Enterography. AJR Am J Roentgenol. 2016 May;206(5):994-1002. doi: 10.2214/AJR.15.15260. Epub 2016 Mar 21.
- Individual participant dataSharing planned: No
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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.
Jonathan Dillman, MD, MSc principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Barium Sulfate and Flavored beverage Oral Contrast in people with Inflammatory Bowel Diseases, run by Children's Hospital Medical Center, Cincinnati 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 2 inclusion and 3 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 13 Feb 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Degree of bowel opacification as determined by estimated percentage of overall small bowel opacification (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT02946203, which also lists 6 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 13 Feb 2018.