Biologics in inflammatory bowel disease (IBD)-need and reasons for discontinuatio

Not Applicable

Completed

• Conditions: Health Condition 1: K50-K52- Noninfective enteritis and colitis

• Registration Number: CTRI/2020/05/025403
• Lead Sponsor: Dr Tarun Gupta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-10-31
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 495

Inclusion Criteria

1. All patients with a confirmed diagnosis of IBD based on diagnostic criteria of IBD

Copenhagen Diagnostic Criteria (UC) (all three criteria must be present):

(i) History of diarrhea and/or rectal bleeding and pus for more than 1 week or repeated episodes.

(ii) Characteristic endoscopic findings of continuous ulceration, vulnerability or granulated mucosa.

(iii) Histopathology consistent with UC (neutrophils within epithelial structures, cryptitis, crypt distortion, crypt abscesses).

Infection and cancer should be ruled out.

Copenhagen Diagnostic Criteria (CD) (at least two criteria must be present):

(i) History of abdominal pain, weight loss and/or diarrhoea for more than 3 months.

(ii) Characteristic endoscopic findings of ulceration (aphthous lesions, snail track ulcerations), or cobble stoning, or radiological features of stricture.

(iii) Histopathology consistent with CD (epithelioid granuloma of Langhans type or transmural, discontinuous focal or patchy inflammation).

(iv) Fistula and/or abscesses in addition to affected bowel segments.

Infection and cancer should be ruled out.

2. Age group: all age groups

Exclusion Criteria

Patients with Inflammatory Bowel Disease (IBD) not giving consent for the study

Study & Design

• Study Type: Observational
• Study Design: Not specified