Bowel Preparation for Magnetic Resonance Enterography

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 14 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients with CD need MRE examination and mid-gut tubing (prepared for fecal microbiota transplantation and/or enteral nutrition); - Age ≥ 14 years old.

Exclusion Criteria:

  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03541733
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The Second Hospital of Nanjing Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Faming Zhang, MD, PhD
Principal Investigator Affiliation The Second Hospital of Nanjing Medical University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Additional Details

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).

Arms & Interventions

Arms

Experimental: Tubing-group

mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube

No Intervention: Oral-group

administer contrast solution orally, mid-gut tubing after the MRE examination

Interventions

Other: - mid-gut tubing

mid-gut tubing at different time

Contact a Trial Team

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International Sites

Fmt-Dt-N-27/1350, Nanjing, Jiangsu, China

Status

Recruiting

Address

Fmt-Dt-N-27/1350

Nanjing, Jiangsu, 210011

Site Contact

Faming Zhang, PhD,MD

fzhang@njmu.edu.cn

086-025-58509883

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