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OpenTrials
Completed

NCT Number: NCT06623383

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

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.

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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