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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

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

Abierto para la inscripción

Contact information:

Katie Dunleavy M.B., B.Ch., B.A.O.

Dunleavy.Katie@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20536644

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