Proteomic Analysis Reveals Innate Immune Activity In Intestinal Transplant Dysfunction

NCT01140152 | Completed DMC

• 1 other identifier: 08-06-058-02A
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients with intestinal failure require intestinal transplantation for survival. Currently, the gold standard for diagnosing acute cellular rejection (ACR) is histological examination of endoscopic biopsies, which are taken invasively and lack sensitivity. A non-invasive method of monitoring for ACR is needed.

Conditions

Intestinal Transplant; Cellular Rejection

Keywords

intestinal transplantation; rejection; proteomics; innate immunity

Outcome Measures

Primary Outcomes (1)

• Evaluate levels of proteins and cytokines in ostomy effluent during episodes of rejection

  Protocol biopsies of the transplanted intestine are obtained during endoscopy and when clinical symptoms indicating abnormal allograft function are present. Biopsies were sent to pathology, where the pathologist determined if there was acute rejection. Ostomy effluent taken during times of endoscopy were subjected to MALDI and Luminex technology to look for any proteins or cytokines differentially expressed during rejection.

  first 8 weeks post transplant

Study Arms (2)

No rejection

Intestinal transplant recipients with no evidence of biopsy proven rejection

Rejection

Intestinal transplant recipients who had evidence of biopsy proven rejection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All Intestinal transplant recipients at UCLA, who are up to 8 weeks status-post transplant and are undergoing surveillance endoscopy or who present with elevated stool outputs with concern for acute rejection. Controls will consist of all primary ITx recipients of the same follow-up criteria who are undergoing surveillance biopsies but are at their baseline ostomy outputs.

You may qualify if:

• Intestinal transplant recipient
• Less than 8 weeks post transplant

You may not qualify if:

• Intestinal transplant recipients more than 8 weeks post transplant

Sponsors & Collaborators

• University of California, Los Angeles: lead
• NIH T32 Human and Molecular Development Training Grant: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Ostomy effluent

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Anjuli R Kumar, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: July 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 14, 2026

Record last verified: 2010-02

Locations

US (1)