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

Sohag University

Status: Not yet enrolling

Conditions: Inflammatory Bowel Disease (IBD); Irritable Bowel Syndrome (IBS)

Study type: Observational

Funder types: Other

Identifiers

NCT07016529

Soh-Med--25-5-9MS

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

100 participants in 3 patient groups

control group "normal"

Description:

normal individuals

case group 1 "patients with lower GIT symptoms suggestive of irritable bowel syndrome"

Description:

those who fulfill the criteria of irritable bowel disease.no intervention needed.

case group 2 "patients with lower GIT symptoms suggestive of inflammatory bowel disease"

Description:

those with bloody diarrhea or chronic diarrhea or other manifestations suggest inflammatory bowel disease.no intervention needed.