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FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms

Diagnostic Performance of Fecal Immunochemical Test and Fecal Calprotectin in Detection of Ileocolonic Lesions in Patients With Chronic Lower Gastrointestinal Symptoms

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05514561
Enrollment
1007
Registered
2022-08-24
Start date
2020-03-22
Completion date
2022-11-01
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Colorectal Adenoma, Colitis

Keywords

Fecal immunochemical test, calprotectin, Colorectal neoplasm, Colorectal cancer, Colitis

Brief 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.

Detailed description

This study was a single-center, prospective cohort study undertaken at Siriraj hospital between March 2020 to November 2022. Eligible participants were required to collect their stool samples one to two days before the bowel preparation. The stool was sent for fresh smear examination, quantitative FIT (OC-SENSOR, EIKEN CHEMICAL, Japan), and quantitative fecal calprotectin (EliA Calprotectin 2, Phadia, Sweden). Blood samples were obtained on the day of the colonoscopy and were tested for complete blood count, albumin, and C-reactive protein (CRP) levels. In addition, clinical information was obtained, including alarm features such as the age of onset older than 50 years, rectal bleeding, anemia, significant weight loss, and family history of colorectal cancer. Colonoscopic findings and histopathological findings were used as the reference standard for diagnosis. We analyzed the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for diagnosing significant ileocolonic lesions, including colorectal cancer, advanced adenoma, and colitis, of each diagnostic modality comparing to the reference standard.

Interventions

DIAGNOSTIC_TESTFecal calprotectin

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

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

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age of at least 18 years * patients with at least one month of any lower gastrointestinal symptoms are as followings; lower abdominal pain, constipation, diarrhea, rectal bleeding, change in stool caliber, abdominal bloating, * patients who are scheduled for a colonoscopy

Exclusion criteria

* incomplete colonoscopy * incomplete stool collection

Design outcomes

Primary

MeasureTime frameDescription
The diagnostic performance of fecal calprotectin in diagnosis of significant ileocolonic lesions1 monthThe sensitivity, specificity, and accuracy of fecal calprotectin in diagnosis of significant ileocolonic lesions, including colorectal cancer, advanced adenoma, and ileocolitis, compared to colonoscopic diagnosis

Secondary

MeasureTime frameDescription
The diagnostic performance of fecal immunochemical test in diagnosis of significant ileocolonic lesions1 monthThe sensitivity, specificity, and accuracy of fecal immunochemical test in diagnosis of significant ileocolonic lesions, including colorectal cancer, advanced adenoma, and ileocolitis, compared to colonoscopic diagnosis

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026