CompletedNot Applicable

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

Thailand120 participantsStarted 2023-10-01

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 year

Trial details

NCT IDNCT06623383

SponsorMahidol University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Inflammatory Bowel Disease trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.