Ulcerative Colitis Clinical Trial
— EARLYOfficial title:
Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease
NCT number | NCT05698745 |
Other study ID # | EARLY |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2024 |
Est. completion date | May 1, 2038 |
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).
Status | Not yet recruiting |
Enrollment | 450 |
Est. completion date | May 1, 2038 |
Est. primary completion date | May 1, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria Patients from cohort A will be included if they fulfill all the following inclusion criteria: - 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. - Time interval between the index colonoscopy and the baseline visit up to 3 months. Patients from cohort B will be included if they fulfill all the following inclusion criteria: - Male or female =18 years of age at baseline. - Recent diagnosis of IBD, with <3 months from symptoms onset. - Time interval between the index colonoscopy and the baseline visit up to 3 months. Patients from cohort C will be included if they fulfill all the following inclusion criteria: - Male or female =18 years of age at baseline. - No endoscopic signs of IBD after a complete ileo-colonoscopy within the CRC screening program. - Time interval between the index colonoscopy and the baseline visit up to 3 months. Exclusion criteria Patients from cohort A will be excluded if they fulfill any the following exclusion criteria: - 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. Patients from cohort B will be excluded if they fulfill any the following exclusion criteria: - Previous use of immunomodulators or biologics for any condition. Patients from cohort C will be excluded if they fulfill any the following exclusion criteria: - Any gastrointestinal symptoms at baseline. - Previous use of immunomodulators or biologics for any condition. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario Dr. Balmis | Alicante | |
Spain | Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona |
Spain | Hospital de Sant Joan Despí Moisès Broggi | Barcelona | |
Spain | Hospital Universitario de Basurto | Bilbao | |
Spain | Hospital Universitario de Burgos | Burgos | |
Spain | Hospital Universitario Reina Sofía | Córdoba | |
Spain | Hospital Universitario Donostia | Donostia | Gipuzkoa |
Spain | Hospital Universitario de Galdakao | Galdakao | Vizcaya |
Spain | Hospital Universitario de Cabueñes | Gijón | Asturias |
Spain | Hospital Universitario de Canarias | La Laguna | Santa Cruz De Tenerife |
Spain | Hospital Universitario de la Princesa | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Ramon y Cajal | Madrid | |
Spain | Althaia, Xarxa Assistencial Universitària de Manresa | Manresa | Barcelona |
Spain | Complejo Hospitalario Universitario de Ourense | Ourense | |
Spain | Hospital Universitario Central de Asturias | Oviedo | Asturias |
Spain | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria |
Spain | Hospital Clínico Universitario de Santiago | Santiago De Compostela | A Coruña |
Spain | Hospital Universitari Mútua de Terrassa | Terrassa | Barcelona |
Spain | Hospital Univeristario y Politécnico La Fe | Valencia | |
Spain | Hospital Universitario Clínico de Valencia | Valencia | |
Spain | Hospital Universitario Río Hortega | Valladolid | |
Spain | Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo) | Vigo | Pontevedra |
Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza | |
Spain | Hospital Universitario Miguel Servet | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa |
Spain,
Rodriguez-Lago I, Merino O, Azagra I, Maiz A, Zapata E, Higuera R, Montalvo I, Fernandez-Calderon M, Arreba P, Carrascosa J, Iriarte A, Portillo I, Aguirre U, Barreiro-de Acosta M, Munoz-Navas M, Cabriada JL. Characteristics and Progression of Preclinical Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2018 Sep;16(9):1459-1466. doi: 10.1016/j.cgh.2017.11.006. Epub 2017 Nov 11. — View Citation
Rodriguez-Lago I, Ramirez C, Merino O, Azagra I, Maiz A, Zapata E, Higuera R, Montalvo I, Fernandez-Calderon M, Arreba P, Carrascosa J, Iriarte A, Munoz-Navas M, Cabriada JL, Barreiro-de Acosta M. Early microscopic findings in preclinical inflammatory bowel disease. Dig Liver Dis. 2020 Dec;52(12):1467-1472. doi: 10.1016/j.dld.2020.05.052. Epub 2020 Jun 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease progression | Development and type of new-onset symptoms during follow-up (mainly diarrhea, abdominal pain, and rectal bleeding). | 10 years | |
Primary | Disease progression | Time to development of symptomatic disease during follow-up. | 10 years | |
Primary | - 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 |
10 years | |
Primary | Omic findings | proteomic, transcriptomic, serologic, microbiota, and tissue data | 10 years | |
Secondary | 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. |
10 years | |
Secondary | Changes in endoscopic features during follow-up | 10 years | ||
Secondary | Microscopic characteristics at diagnosis | 10 years | ||
Secondary | Clinical disease activity during follow-up | 10years | ||
Secondary | Development and time to development of need for medical or surgical therapy during follow-up | 10years | ||
Secondary | Development and time to development of extraintestinal manifestations during follow-up | 10years | ||
Secondary | Type of extraintestinal manifestations during follow-up | 10years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05702879 -
Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
|
||
Not yet recruiting |
NCT05953402 -
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
|
||
Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
Recruiting |
NCT03950232 -
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
Completed |
NCT03124121 -
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
|
Phase 4 | |
Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
Withdrawn |
NCT04209556 -
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
|
Phase 2 | |
Terminated |
NCT00061282 -
Clotrimazole Enemas for Pouchitis in Children and Adults
|
Phase 1/Phase 2 | |
Recruiting |
NCT04398550 -
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
|
N/A | |
Recruiting |
NCT04314375 -
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
|
Phase 4 | |
Active, not recruiting |
NCT04857112 -
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
|
Phase 2 | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Active, not recruiting |
NCT04033445 -
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
Active, not recruiting |
NCT06221995 -
Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
|
||
Recruiting |
NCT04767984 -
Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis
|
Phase 2 | |
Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
Recruiting |
NCT06071312 -
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
|
Phase 1/Phase 2 | |
Completed |
NCT03760003 -
Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
|
Phase 2 | |
Not yet recruiting |
NCT05539625 -
Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis
|
Phase 2 |