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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-10

Study Completion Date

2025-12-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control group "normal"

normal individuals

No interventions assigned to this group

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

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

No interventions assigned to this group

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

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes