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A Study to Identify Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

Overview

Información sobre este estudio

The purpose of this study is to evaluate if specific blood, stool and MRI tests can tell the difference between bowel wall inflammation without scarring and bowel wall inflammation with scarring that can cause bowel blockages requiring surgery.

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: 

Aim 1 (CD participants)

  • Aged 8-70 years old.
  • Undergoing first surgical distal (ileal) small bowel resection for structuring (B2 phenotype) Crohn's disease as determined by CTE or MRE or ileocolonoscopy.
  • English speaking.

Aim 2 (CD participants)

  • Age 8 to 70 years old.
  • Uncomplicated inflammatory small bowel CD based on clinical CTE or MRE or ileocolonoscopy performed within 6 months prior to enrollment (CD participants only).
  • English speaking.

Aim 2 (Control participants)

  • Age 8 to 70 years old. 
  • English speaking.

Exclusion Criteria: 

Aim1 (CD participants)

  • B1 or B3 (i.e., fistula, abscess, phlegmon/inflammatory mass) CD phenotype.
  • Prior small bowel surgery, including but not limited to surgical resection, stricturoplasty, or endoscopic treatment of a small bowel stricture.
  • Anything to eat or drink within 4 hours of study visit (participants may take their required medications with a little water).
  • Known pregnancy (Note: Institutional policies/procedures will be followed for pregnancy screening).
  • Contraindication for MRI (e.g., surgical implant, claustrophobia).
    • Note: To be determined based on local procedures. 

Aim 2 (CD participants)

  • Stenotic ileocecal valve at colonoscopy.
  • Prior small bowel surgery, including but not limited to surgical resection, stricturoplasty, or endoscopic treatment of a small bowel stricture.
  • Anything to eat or drink within 4 hours of study visit (participants may take their required medications with a little water).
  • Known pregnancy.
    • Note: Institutional policies/procedures will be followed for pregnancy screening.
  • Contraindication for MRI (e.g., surgical implant, claustrophobia).
    • Note: To be determined based on local procedures.

Aim 2 (Control participants) 

  • Any known gastrointestinal tract disease.
  • Any known inflammatory/autoimmune disease involving another organ system (e.g., rheumatoid arthritis, scleroderma, multiple sclerosis).
  • Fecal calprotectin level of ˃100 mcg.gm will be excluded from further analysis and replaced.

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

David Bruining, M.D.

Cerrado para la inscripción

Contact information:

Brenda Becker CCRP

(507)266-0111

Brenda.Becker1@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20470674

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