Recruiting

Observational Study

Sponsor:

University of Texas at Austin

Code:

NCT04617184

Conditions

Crohn Disease

Ulcerative Colitis

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NO INTERVENTION

Study Details

Brief summary:

This is a prospective, non-interventional registry and biorepository for patients with IBD. Longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters. The biorepository will consist of prospective collection of blood samples, tissue samples, and fecal samples for research purposes, while the participants are undergoing a clinically-indicated procedure (i.e. venipuncture for routine tests, IV catheter placement, and/or endoscopy). Participants may choose to provide any or all of the aforementioned information and/or samples.

Conditions

Crohn Disease

Ulcerative Colitis

Inflammatory Bowel Diseases

Study ID

NCT04617184

Start date

Jun 1, 2021

Status verified date

May, 2021

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female, age 18 years or older
  • Willing and able to provide written consent for participation in the registry and biorepository
  • Patients with known or suspected inflammatory bowel disease

Exclusion Criteria:

  • Patient is unable to comprehend and/or cooperate with study activities
  • Patient is too ill to provide consent
  • Coagulopathy that precludes safe biopsy of the bowel
  • Comorbidity that precludes safe participation in endoscopic procedures

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Inflammatory Bowel Disease

any patient with IBD will be included in the registry

Interventions

NO INTERVENTION

THERE IS NO INTERVENTION TO THIS TRIAL. THIS IS A REGISTRY

Primary outcome measure

  • Number of patients with inflammatory bowel disease [ Time Frame: 10 YEARS ]

Central Contacts and Locations

Central contacts

Locations

Dell Medical School, UT Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

More Information

Sponsor

University of Texas at Austin

Last update posted

May 18, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2021-05-18.