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NCT Number: NCT07016529

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

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

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Key information

Conditions

Irritable Bowel Syndrome (IBS) Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease (IBD) Inflammatory Bowel Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: baseline

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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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