Developing a Non-invasive Test to Detect Intestinal Inflammation in Active Inflammatory Bowel Disease

Overview

About this study

The purpose of this study is to measure small intestinal and colonic permeability in 20 patients with active Inflammatory Bowel Disease (IBD), 20 patients with IBD in remission, and to compare with already acquired data from 60 healthy controls.

A subsidiary aim is to acquire new data in 20 healthy controls in order to ensure that the measurements of intestinal and colonic permeability in this cohort are consistent with those previously acquired in 60 healthy controls whose diet was standardized by meals prepared by the diet kitchen.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Recruitment of 40 IBD patients (20 with active IBD, 20 with IBD in remission, with equal numbers of Crohn’s (CD) and ulcerative colitis (UC)) with thoroughly evaluated IBD (endoscopy, histopathology, or CT enterography):

Active disease as defined by SES-CD (PMID: 15472670) > 6 (> 4 if ileal only), AND active symptoms of CD (CDAI score > 220) or full Mayo score for UC ≥ 2 with an endoscopy score of ≥2 (PMID: 31272578) within the past 4-6 weeks. 9,10,11,12,13
Remission as defined by SES-CD 0-2 and CDAI score ≤150, or full Mayo score for UC 0-2 with endoscopy score < 2.9,10,11,12,13.
Ability to give informed consent.

Healthy Adults

≥ 18 years age.
No underlying medical illnesses that could serve as confounders with the objectives of the study.

Exclusion Criteria:

Recruitment of 40 IBD patients (20 with active IBD, 20 with IBD in remission, with equal numbers of Crohn’s (CD) and ulcerative colitis (UC)) with thoroughly evaluated IBD (endoscopy, histopathology, or CT enterography):

Less than 18 years of age.
Prior history gastrointestinal surgeries including IPAA, ileostomy and colostomy.
Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test.
Use of osmotic laxatives and unable to unwilling to stop taking one week prior to permeability test.
Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous two weeks and for the duration of the study.
Multiple dietary restrictions or unable or unwilling to alter dietary protein or dietary fiber for the permeability testing.
Unwilling or unable to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages.
Bowel preparation for colonoscopy must be completed more than 48 hours prior to completion of permeability test. If intestinal biopsies were performed, 7 days must pass prior to permeability testing.
Pregnancy or plan to become pregnant during the study time frame.
Vulnerable adult.

Healthy Adults

Less than 18 years of age.

Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Michael Camilleri, M.D., D.Sc.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D., D.Sc.

Closed for enrollment

More information

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