FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms

NCT ID: NCT05514561

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1007 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-22
• Study Completion Date: 2022-11-01

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.

Conditions

Colorectal Cancer; Colorectal Adenoma; Colitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with chronic lower gastrointestinal symptoms

We enroll adults older than 18 years with chronic lower GI symptoms for more than 1 month and are scheduled for a colonoscopy. The lower GI symptoms consist of any of the followings; lower abdominal pain, constipation, diarrhea, rectal bleeding, change in stool caliber, and abdominal bloating.

Fecal calprotectin

Intervention Type: DIAGNOSTIC_TEST

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

Fecal immunochemical test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Fecal calprotectin

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

Intervention Type: DIAGNOSTIC_TEST

Fecal immunochemical test

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Julajak Limsrivilai

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julajak Limsrivilai, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

References

Limsrivilai J, Yodmalai C, Chaemsupaphan T, Sattayalertyanyong O, Subdee N, Permpim P, Phaophu P, Kaosombatwattana U, Pausawasdi N, Riansuwan W, Charatcharoenwitthaya P, Pongprasobchai S. Evaluating the Efficacy of Fecal Immunochemical Test, Fecal Calprotectin, and Serum C-Reactive Protein in Diagnosing Patients With Chronic Lower Gastrointestinal Symptoms. Clin Transl Gastroenterol. 2024 Aug 1;15(8):e00747. doi: 10.14309/ctg.0000000000000747.

Reference Type: DERIVED

PMID: 38994833 (View on PubMed)

Other Identifiers

Si238/2020

Identifier Type: -

Identifier Source: org_study_id