Diagnostic Study for Differentiating Functional From Organic Diseases in Patients With Lower GIT Symptoms

Diagnostic Utility of Myeloperoxidase for Differentiating Irritable Bowel Syndrome From Inflammatory Bowel Disease in Patients With Lower GIT Symptoms

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07016529

Enrollment

100

Registered

2025-06-11

Start date

2025-06-10

Completion date

2025-12-20

Last updated

2025-06-11

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

Conditions

Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS)

Brief summary

The study is intended to find a new trusted, cost-effective biomarker for differentiating irritable bowel syndrome from inflammatory bowel disease to decrease the use of unnecessary invasive methods in patients with irritable bowel syndrome

Detailed description

Myeloperoxidase is a lysosomal protein that is released from granules of neutrophil granulocytes during inflammation. the study design relies on the fact that there is no mucosal inflammation in case of functional gastrointestinal tract (GIT) disorders like irritable bowel syndrome (IBS), but organic gastrointestinal conditions like inflammatory bowel diseases (IBD) has mucosal inflammation and neutrophil influx into the mucosa. the study is designed to assess myeloperoxidase levels in both conditions and assessing its reliability in differentiation between them.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Adults (≥18 years) presenting with chronic lower gastrointestinal symptoms, such as diarrhea, abdominal pain, or altered bowel habits, for a duration exceeding 6 weeks. * Patients with no prior diagnosis of IBD or IBS. * Patients willing to provide informed consent and comply with study requirements. * Those without recent use of immunosuppressants or anti-inflammatory medications that could affect biomarker levels

Exclusion criteria

* Patients with a confirmed diagnosis of IBD and currently on treatment. * Those with acute gastroenteritis, infectious colitis, or positive stool cultures for pathogens. * Patients diagnosed with colorectal cancer, celiac disease, or other known organic GI disorders. * Recent antibiotic, NSAID, or corticosteroid use within the past 4 weeks. * Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame	Description
efficacy of myeloperoxidase for differentiating irritable bowel syndrome from inflammatory bowel disease.	baseline	Number of patients with elevated myeloperoxidase in irritable bowel syndrome and those with inflammatory bowel disease.

Outcome results