Diagnostic Study for Differentiating Functional From Organic Diseases in Patients With Lower GIT Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Diagnostic Utility of Myeloperoxidase for Differentiating Irritable Bowel Syndrome From Inflammatory Bowel Disease in Patients With Lower GIT Symptoms
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
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.
Primary outcome measures
- efficacy of myeloperoxidase for differentiating irritable bowel syndrome from inflammatory bowel disease. [Time frame: baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07016529 · Soh-Med--25-5-9MS