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

N/ANot Yet RecruitingNCT07016529

Sohag University100 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

efficacy of myeloperoxidase for differentiating irritable bowel syndrome from inflammatory bowel disease.

Number of patients with elevated myeloperoxidase in irritable bowel syndrome and those with inflammatory bowel disease.

Time frame: baseline

Data from ClinicalTrials.gov

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