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Stricture Definition and Treatment (STRIDENT) Drug Therapy Study | Clinical Trials | Clareo Health

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Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

NCT03220841•St Vincent's Hospital Melbourne

Summary

Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.

Detailed Description

Prospective randomised controlled study. Patients with Crohn's Disease who have symptomatic inflammatory intestinal strictures will be randomised to receive standard drug therapy (Anti-TNF monotherapy at standard dose) or intensive drug therapy (Intense Anti-TNF dose induction and escalation for continued inflammation in combination with thiopurine) for 12 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.

Exclusion Criteria

•Acute bowel obstruction requiring urgent surgical intervention
•Deemed by treating physician to have high risk of acute bowel obstruction
•Concurrent active perianal sepsis
•Internal fistulising disease in association with strictures (entero-enteric stulas)
•Low rectal or anal strictures
•Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
•Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
•Inability to give informed consent
•Suspected perforation of the gastrointestinal tract
•Pregnancy
+1 more criteria

Locations (1)

St. Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Key Dates

Start Date

October 9, 2017

Primary Completion Date

September 18, 2020

Completion Date

September 1, 2021

Last Updated

October 23, 2020

Enrollment

ACTUAL participants

Conditions

Crohn DiseaseInflammatory Bowel DiseasesStricture; Bowel

Interventions

Adalimumab Injection

DRUG

Thiopurine

DRUG

Endoscopic balloon dilatation

PROCEDURE

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITING

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

NCT07245394

Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Immunological Characteristics of Preclinical IBD

Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study

Institutional Registry of Rare Diseases