Crohn DiseaseNCT03541733
Bowel Preparation for Magnetic Resonance Enterography
A study testing mid-gut tubing in people with Crohn Disease, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
Adequate bowel preparation is required for magnetic resonance enterography (MRE) which can be achieved by two methods including administering contrast solution after mid-gut tubing and taking contrast solution orally. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- mid-gut tubing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 28 Feb 2023
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with CD need MRE examination and mid-gut tubing (prepared for fecal microbiota transplantation and/or enteral nutrition);
- Age ≥ 14 years old.
Who cannot join
- Unable to understand or provide informed consent;
- Had difficulty in swallowing, or dysphagia;
- Allergic to laxative and/or contrast;
- Claustrophobia or implanted metal objects or cardiac pacemaker precluding performance of MRI;
- Known or suspected intestinal obstruction or severe stricture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Bowel Preparation for Magnetic Resonance Enterography: a Open Label, Multicenter Randomized Controlled Trial
Adequate bowel preparation is required for magnetic resonance enterography (MRE) which can be achieved by two methods including administering contrast solution after mid-gut tubing and taking contrast solution orally. We present the design of randomized controlled trial to compare the efficacy and compliance of bowel preparation through mid-gut tubing with taking contrast orally for MRE in patients with Crohn's disease (CD).
Read the detailed description
This is a open label, multicenter, randomized controlled trial. 96 patients are planed to be 1:1 randomized into one of two groups: (1) Tube group, mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube; (2) Oral group, administer contrast solution orally, mid-gut tubing after the MRE examination. The primary outcome measures are: (1) grade of bowel distention evaluated by a 5-grade scale (1 = 0-20% segmental distention, 2 = 20-40% distention, 3 = 40-60% distention, 4 = 60-80% distention, 5 = 80-100% distention); (2) degree of discomfort before/during/after bowel preparation for MRE using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe). The secondary outcome measure is the accuracy of lesion detection through MRE confirmed by endoscopy (within 1 month before MRE and during this hospitalization) will be evaluated by a 5-point scale (lesions locating at the terminal ileum, ileocecal junction, hepatic flexure of colon, splenic flexure of colon, and rectosigmoid colon, consistency of lesion detection from each bowel segment scoring 1 point, otherwise not scoring).
- Conditions
- Crohn Disease
- Being tested
- mid-gut tubing
- Keywords
- magnetic resonance enterography, bowel preparation
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mid-gut tubingOther
mid-gut tubing at different time
| Study group | Role | What they receive |
|---|---|---|
| Tubing-group | Experimental | mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube Receives: Other: mid-gut tubing |
| Oral-group | No intervention | administer contrast solution orally, mid-gut tubing after the MRE examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
grade of bowel distention
grade of bowel distention evaluated by a 5-grade scale (1 = 0-20% segmental distention, 2 = 20-40% distention, 3 = 40-60% distention, 4 = 60-80% distention, 5 = 80-100% distention)
Measured: one year
degree of discomfort
using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe)
Measured: one year
Secondary outcomes (1)
accuracy of lesion detection
accuracy of lesion detection through MRE confirmed by endoscopy (within 1 month before MRE and during this hospitalization) will be evaluated by a 5-point scale (lesions locating at the terminal ileum, ileocecal junction, hepatic flexure of colon, splenic flexure of colon, and rectosigmoid colon, consistency of lesion detection from each bowel segment scoring 1 point, otherwise not scoring)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Jun 2018
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Wuxi No. 2 People's Hospital
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, MD, PhD, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541733
- Sponsor's protocol ID
- MRE-CN-180421
- Status last verified
- Apr 2023
- First submitted
- 5 May 2018
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ajaj W, Goehde SC, Schneemann H, Ruehm SG, Debatin JF, Lauenstein TC. Oral contrast agents for small bowel MRI: comparison of different additives to optimize bowel distension. Eur Radiol. 2004 Mar;14(3):458-64. doi: 10.1007/s00330-003-2177-0. Epub 2003 Nov 22.
PubMed 14634782Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.
PubMed 25168749Masselli G, Casciani E, Polettini E, Gualdi G. Comparison of MR enteroclysis with MR enterography and conventional enteroclysis in patients with Crohn's disease. Eur Radiol. 2008 Mar;18(3):438-47. doi: 10.1007/s00330-007-0763-2. Epub 2007 Sep 25.
PubMed 17899102Negaard A, Paulsen V, Sandvik L, Berstad AE, Borthne A, Try K, Lygren I, Storaas T, Klow NE. A prospective randomized comparison between two MRI studies of the small bowel in Crohn's disease, the oral contrast method and MR enteroclysis. Eur Radiol. 2007 Sep;17(9):2294-301. doi: 10.1007/s00330-007-0648-4. Epub 2007 May 5.
PubMed 17483955Long C, Yu Y, Cui B, Jagessar SAR, Zhang J, Ji G, Huang G, Zhang F. A novel quick transendoscopic enteral tubing in mid-gut: technique and training with video. BMC Gastroenterol. 2018 Mar 13;18(1):37. doi: 10.1186/s12876-018-0766-2.
PubMed 29534703Wang Y, Dai M, Zheng M, Jin Y, Wen Q, Cui B, Zhang Z, Zhu J, Zhang F. Bowel preparation after mid-gut tubing enhanced the efficacy and compliance of magnetic resonance enterography in Crohn's disease: a randomized controlled trial. Ther Adv Gastroenterol. 2024 Sep 26;17:17562848241275337. doi: 10.1177/17562848241275337. eCollection 2024.
PubMed 39346010Dai M, Zhang T, Li Q, Cui B, Xiang L, Ding X, Rong R, Bai J, Zhu J, Zhang F. The bowel preparation for magnetic resonance enterography in patients with Crohn's disease: study protocol for a randomized controlled trial. Trials. 2019 Jan 3;20(1):1. doi: 10.1186/s13063-018-3101-x.
PubMed 30606236
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bowel Preparation for Magnetic Resonance Enterography: a Open Label, Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03541733
- Acronym / sponsor ID
- MRE-CN-180421
- Conditions
- Crohn Disease
- Keywords
- magnetic resonance enterography, bowel preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Wuxi No. 2 People's Hospital
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 30 May 2018 (actual)
- 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.
Adequate bowel preparation is required for magnetic resonance enterography (MRE) which can be achieved by two methods including administering contrast solution after mid-gut tubing and taking contrast solution orally. We present the design of randomized controlled trial to compare the efficacy and compliance of bowel preparation through mid-gut tubing with taking contrast orally for MRE in patients with Crohn's disease (CD).
Detailed description
This is a open label, multicenter, randomized controlled trial. 96 patients are planed to be 1:1 randomized into one of two groups: (1) Tube group, mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube; (2) Oral group, administer contrast solution orally, mid-gut tubing after the MRE examination. The primary outcome measures are: (1) grade of bowel distention evaluated by a 5-grade scale (1 = 0-20% segmental distention, 2 = 20-40% distention, 3 = 40-60% distention, 4 = 60-80% distention, 5 = 80-100% distention); (2) degree of discomfort before/during/after bowel preparation for MRE using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe). The secondary outcome measure is the accuracy of lesion detection through MRE confirmed by endoscopy (within 1 month before MRE and during this hospitalization) will be evaluated by a 5-point scale (lesions locating at the terminal ileum, ileocecal junction, hepatic flexure of colon, splenic flexure of colon, and rectosigmoid colon, consistency of lesion detection from each bowel segment scoring 1 point, otherwise not scoring).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tubing-group | Experimental | Other: mid-gut tubingmid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube |
| Oral-group | No intervention | –administer contrast solution orally, mid-gut tubing after the MRE examination |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with CD need MRE examination and mid-gut tubing (prepared for fecal microbiota transplantation and/or enteral nutrition);
- Age ≥ 14 years old.
Key exclusion criteria (5 listed)
- Unable to understand or provide informed consent;
- Had difficulty in swallowing, or dysphagia;
- Allergic to laxative and/or contrast;
- Claustrophobia or implanted metal objects or cardiac pacemaker precluding performance of MRI;
- Known or suspected intestinal obstruction or severe stricture.
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 |
|---|---|---|
| mid-gut tubingmid-gut tubing at different time | Other | Tubing-group |
Primary outcome
grade of bowel distention
Time frame: one year
grade of bowel distention evaluated by a 5-grade scale (1 = 0-20% segmental distention, 2 = 20-40% distention, 3 = 40-60% distention, 4 = 60-80% distention, 5 = 80-100% distention)
degree of discomfort
Time frame: one year
using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe)
1 secondary outcome
accuracy of lesion detection
Time frame: one 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 4 Apr 2023.
- Background: PubMed 14634782Ajaj W, Goehde SC, Schneemann H, Ruehm SG, Debatin JF, Lauenstein TC. Oral contrast agents for small bowel MRI: comparison of different additives to optimize bowel distension. Eur Radiol. 2004 Mar;14(3):458-64. doi: 10.1007/s00330-003-2177-0. Epub 2003 Nov 22.
- Background: PubMed 25168749Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.
- Background: PubMed 17899102Masselli G, Casciani E, Polettini E, Gualdi G. Comparison of MR enteroclysis with MR enterography and conventional enteroclysis in patients with Crohn's disease. Eur Radiol. 2008 Mar;18(3):438-47. doi: 10.1007/s00330-007-0763-2. Epub 2007 Sep 25.
- Background: PubMed 17483955Negaard A, Paulsen V, Sandvik L, Berstad AE, Borthne A, Try K, Lygren I, Storaas T, Klow NE. A prospective randomized comparison between two MRI studies of the small bowel in Crohn's disease, the oral contrast method and MR enteroclysis. Eur Radiol. 2007 Sep;17(9):2294-301. doi: 10.1007/s00330-007-0648-4. Epub 2007 May 5.
- Background: PubMed 29534703Long C, Yu Y, Cui B, Jagessar SAR, Zhang J, Ji G, Huang G, Zhang F. A novel quick transendoscopic enteral tubing in mid-gut: technique and training with video. BMC Gastroenterol. 2018 Mar 13;18(1):37. doi: 10.1186/s12876-018-0766-2.
- Derived from this study: PubMed 39346010Wang Y, Dai M, Zheng M, Jin Y, Wen Q, Cui B, Zhang Z, Zhu J, Zhang F. Bowel preparation after mid-gut tubing enhanced the efficacy and compliance of magnetic resonance enterography in Crohn's disease: a randomized controlled trial. Ther Adv Gastroenterol. 2024 Sep 26;17:17562848241275337. doi: 10.1177/17562848241275337. eCollection 2024.
- Derived from this study: PubMed 30606236Dai M, Zhang T, Li Q, Cui B, Xiang L, Ding X, Rong R, Bai J, Zhu J, Zhang F. The bowel preparation for magnetic resonance enterography in patients with Crohn's disease: study protocol for a randomized controlled trial. Trials. 2019 Jan 3;20(1):1. doi: 10.1186/s13063-018-3101-x.
- Individual participant dataSharing planned: Undecided
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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.
Faming Zhang, MD, PhD principal investigator
The Second Hospital of Nanjing Medical 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 mid-gut tubing in people with Crohn Disease, run by The Second Hospital of Nanjing Medical University at 1 site in China.
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 5 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 4 Apr 2023. 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 China. 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?
grade of bowel distention (time frame: one year). The study lists 2 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 NCT03541733, which also lists 7 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 4 Apr 2023.