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FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms

NCT05514561 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1007

Last updated 2023-03-14

No results posted yet for this study

Summary

Chronic lower gastrointestinal (GI) symptoms, including lower abdominal pain, bowel habit change, bleeding per rectum, and abdominal bloating, are caused by functional gastrointestinal disorders (FGID) and organic intestinal disorders, including colorectal cancer and chronic colitis. The presence of alarming features, such as the age of onset older than 50 years, rectal bleeding, anemia, significant weight loss, and family history of colorectal cancer, indicates organic diseases, and colonoscopy should be required. However, using only alarming features may not be sufficiently accurate. For example, anemia or significant weight loss, which are highly specific for organic disorders, usually occur in late-stage diseases. Conversely, the parameters with high sensitivity, such as the age of onset after 50 years, have a low specificity; colonoscopy in these patients may not be urgent. Therefore, tests that can help discriminate organic from functional diseases are warranted. Immunochemical fecal occult blood tests (iFOBT) and fecal calprotectin (FC) are biomarkers that indicate organic lesions in the gastrointestinal tract and could help diagnose patients with lower GI symptoms more accurately.

Conditions

Interventions

DIAGNOSTIC_TEST

Fecal calprotectin

To calculate the diagnostic accuracy of fecal calprotectin in the diagnosis of significant ileocolonic lesions

DIAGNOSTIC_TEST

Fecal immunochemical test

To calculate the diagnostic accuracy of the fecal immunochemical test in the diagnosis of significant ileocolonic lesions

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Julajak Limsrivilai, MD, MS · Siriraj Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-22
Primary Completion
2022-11-01
Completion
2022-11-01

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05514561 on ClinicalTrials.gov