Irritable Bowel Syndrome (IBS)NCT07016529
Diagnostic Study for Differentiating Functional From Organic Diseases in Patients With Lower GIT Symptoms
An observational study of Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD), run by Sohag University.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2025to 20 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with lower GIT symptoms seeking medical advice at Department of Internal Medicine, Gastroenterology Outpatient Clinic, Sohag University Hospital
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Diagnostic Utility of Myeloperoxidase for Differentiating Irritable Bowel Syndrome From Inflammatory Bowel Disease 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
Read the 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.
- Medical subject headings
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control group "normal" | normal individuals | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start10 Jun 2025 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mohammad Abd-ellatif, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016529
- Sponsor's protocol ID
- Soh-Med--25-5-9MS
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of Myeloperoxidase for Differentiating Irritable Bowel Syndrome From Inflammatory Bowel Disease in Patients With Lower GIT Symptoms
- ClinicalTrials.gov ID
- NCT07016529
- Acronym / sponsor ID
- Soh-Med--25-5-9MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group "normal" | – | –normal individuals |
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with lower GIT symptoms seeking medical advice at Department of Internal Medicine, Gastroenterology Outpatient Clinic, Sohag University Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD), run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of myeloperoxidase for differentiating irritable bowel syndrome from inflammatory bowel disease. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.