NCT02314949

Brief Summary

An immunomodulatory protocol, experimentally-proven to promote T-regulatory dependent graft protective mechanisms was applied in a clinical cohort of 13 intestinal transplant recipients to activate - in a protolerogenic environment - T-regulatory cells. This protocol is the standard of care in the investigators intestinal transplant programme since the first intestinal transplant was performed in october 2000.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
14.2 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

24.3 years

First QC Date

November 26, 2014

Last Update Submit

July 12, 2024

Conditions

Organ TransplantationIntestine

Keywords

T-regulatory cellsTolerogenic protocolimmunomodulation

Outcome Measures

Primary Outcomes (1)

  • Survival

    routine clinical follow-up and Kaplan Meier Analysis

    10 years

Secondary Outcomes (2)

  • T-regulatory cells CD4+ CD45RA- Foxp3hi

    10 years

  • rejection

    10 years

Study Arms (1)

intestinal transplantation

all performed intestinal transplants underwent the same Leuven intestinal transplant protocol

Procedure: intestinal transplantation

Interventions

intestinal transplantationPROCEDURE
intestinal transplantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent intestinal transplantation

You may qualify if:

  • all patients awaiting intestinal transplantation

You may not qualify if:

  • living donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

  • Ceulemans LJ, Braza F, Monbaliu D, Jochmans I, De Hertogh G, Du Plessis J, Emonds MP, Kitade H, Kawai M, Li Y, Zhao X, Koshiba T, Sprangers B, Brouard S, Waer M, Pirenne J. The Leuven Immunomodulatory Protocol Promotes T-Regulatory Cells and Substantially Prolongs Survival After First Intestinal Transplantation. Am J Transplant. 2016 Oct;16(10):2973-2985. doi: 10.1111/ajt.13815. Epub 2016 May 12.

    PMID: 27037650DERIVED

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Central Study Contacts

Jacques Pirenne, MD,PhD,MsC

CONTACT

+32 16 34 87 27jacques.pirenne@uzleuven.be

Laurens J Ceulemans, MD

CONTACT

+32 16 34 15 45laurens.ceulemans@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2014

First Posted

December 11, 2014

Study Start

October 1, 2000

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

July 15, 2024

Record last verified: 2024-07

Locations

BE(1)