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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colitis; Colorectal Adenoma
• Intervention / Treatment: Diagnostic test: Fecal calprotectin; Diagnostic test: Fecal immunochemical test

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.

• Study Type: Observational
• Enrollment (Actual): 1007

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We enrolled adults older than 18 years with chronic lower GI symptoms for more than 1 month and were scheduled for a colonoscopy. The lower GI symptoms consisted of any of the followings; lower abdominal pain, constipation, diarrhea, rectal bleeding, change in stool caliber, and abdominal bloating. The stool samples were collected one to two days before the bowel preparation. All patients provided written informed consent. Patients who did not return their stool samples and whose complete colonoscopy was not achieved were excluded.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic performance of fecal calprotectin in diagnosis of significant ileocolonic lesions	The sensitivity, specificity, and accuracy of fecal calprotectin in diagnosis of significant ileocolonic lesions, including colorectal cancer, advanced adenoma, and ileocolitis, compared to colonoscopic diagnosis	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic performance of fecal immunochemical test in diagnosis of significant ileocolonic lesions	The 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	1 month

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Julajak Limsrivilai, MD, MS, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2020
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal cancer; Colitis; Colorectal neoplasm; Fecal immunochemical test; calprotectin
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma; Colitis
• Other Study ID Numbers: Si238/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No