Correlation of Fecal Calprotectin and Fecal Immunochemical Test in Determination of Endoscopic Activity in Inflammatory Bowel Disease Patients

NCT06623383 | Completed DMC

• 1 other identifier: 579/2566(IRB2)
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory bowel disease (IBD) patients often experience a long disease course with periods of remission and flare-ups. Currently, in addition to assessing disease stages based on symptoms, colonoscopy performed by specialized physicians is considered the standard for accurately monitoring disease activity. This procedure allows direct visualization of intestinal lesions. However, colonoscopy is complex, costly, carries the risk of complications, and is not suitable for frequent monitoring. This study aims to explore whether stool tests such as calprotectin and immunochemical tests, which are now standard for assessing disease activity in IBD, correlate with colonoscopy results. It also aims to assess the efficacy of these stool tests in determining whether the disease is in remission or active. The objective of the study is to investigate the correlation and efficacy of stool test results, calprotectin and fecal immunochemical test, compared to colonoscopy in patients with IBD.

Conditions

Inflammatory Bowel Disease

Keywords

IBD; inflammatory bowel disease; endoscopy; fecal calprotectin

Outcome Measures

Primary Outcomes (1)

• To study the correlation between fecal calprotectin and fecal immunochemical test for hemoglobin results and endoscopic scores from colonoscopy in patients with inflammatory bowel disease

  To study the correlation between fecal calprotectin and fecal immunochemical test for hemoglobin results and endoscopic scores from colonoscopy in patients with inflammatory bowel disease.

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IBD patients follow-up at Siriraj Hospital, Bangkok, Thailand

You may qualify if:

• Patients aged 18 years or older.
• Diagnosed with inflammatory bowel disease, either ulcerative colitis or Crohn's disease.
• Scheduled for colonoscopy for various indications, including:
• Follow-up after treatment to assess disease remission
• Clinical symptoms or laboratory results suggesting disease flare, such as increased abdominal pain, more frequent diarrhea, or elevated inflammatory markers in the blood
• Screening for colorectal cancer in patients with long-standing inflammatory bowel disease.

You may not qualify if:

• Patients who decline participation in the research project. Incomplete or unsuccessful colonoscopy.
• Failure to provide stool samples.
• Patients hospitalized for reasons unrelated to inflammatory bowel disease.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 20, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)