Registry and Biorepository for IBD in Central Texas

Registry and Biorepository for the Study of Inflammatory Bowel Diseases in Central Texas

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Other: NO INTERVENTION

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Benjamin Chebaa, BA; Phone Number: 5124955641; Email: benjamin.chebaa@austin.utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • Dell Medical School, UT Austin
      • Contact: Banjamin Chebaa, BA; Phone Number: 512-495-5641; Email: benjamin.chebaa@austin.utexas.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients with a diagnosis or suspected diagnosis of IBD made by the treating medical team will be considered for recruitment and enrollment. No special populations are targeted for accrual to this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inflammatory Bowel Disease; any patient with IBD will be included in the registry	Other: NO INTERVENTION; THERE IS NO INTERVENTION TO THIS TRIAL. THIS IS A REGISTRY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with inflammatory bowel disease	Number of patients with Crohns, ulcerative colitis, and IBD undetermined	10 YEARS

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2030
• Study Completion (ANTICIPATED): December 31, 2030

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (ACTUAL): November 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: 2019-07-0137

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No