Health TrialsbyHealthPanel

Immunological Characteristics of Preclinical IBD

ConditionsCrohn DiseaseUlcerative ColitisIBD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

About this trial

The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female ≥18 years of age at baseline.

New diagnosis of IBD during a CRC screening colonoscopy, based on the criteria from the European Crohn's and Colitis Organization (33, 34).

Presence of a chronic inflammatory infiltrate and histological diagnosis compatible with IBD.

The patient must be asymptomatic at diagnosis and without previous symptoms suggestive of IBD.

Disqualifiers

Identification of any enteropathogen in the stool culture.

Isolated findings of acute inflammatory infiltrate without signs of chronicity.

Previous or current diagnosis of microscopic colitis.

Alteration in biomarkers in blood or stool will not constitute an exclusion criterion.

Trial population

All patients with a new diagnosis of IBD

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • bioespecimen samples

    Procedure/Surgery

    Blood, serum, plasma, urine, stools, small/large bowel tissue.

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: Cohort A (preclinical IBD)1 intervention
Group B: Cohort B (control)1 intervention
Group C: Cohort C (control)1 intervention

Trial outcomes

Primary outcomes

1

Disease progression

Development and type of new-onset symptoms during follow-up (mainly diarrhea, abdominal pain, and rectal bleeding).

Time frame
10 years
2

Disease progression

Time to development of symptomatic disease during follow-up.

Time frame
10 years
3

- IBD characteristics

* Type (CD or UC) * Disease extent (CD or UC) according to Montreal classification * CD phenotype at diagnosis (Montreal classification) * Endoscopic characteristics at diagnosis (both CD and UC): type of lesions, distribution, and extent * Presence and type (simple, complex fistula or abscess) of perianal disease at diagnosis and during follow-up

Time frame
10 years
4

Omic findings

proteomic, transcriptomic, serologic, microbiota, and tissue data

Time frame
10 years

Secondary outcomes

1

IBD characteristics:

* Development and time to development of changes in CD disease location, according to Montreal classification. * Development and time to development of new-onset or stricturing, penetrating or perianal complications, defined as changes in CD phenotype (Montreal classification) * Development of proximal disease extension in UC * Laboratory parameters: FOBT levels at diagnosis, and CRP, hemoglobin, albumin, fecal calprotectin at diagnosis and during follow-up.

Time frame
10 years
2

Changes in endoscopic features during follow-up

Time frame
10 years
3

Microscopic characteristics at diagnosis

Time frame
10 years
4

Clinical disease activity during follow-up

Time frame
10years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Lead sponsor

Source ClinicalTrials.gov
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