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

NCT07016529 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med--25-5-9MS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with lower GIT symptoms seeking medical advice at Department of Internal Medicine, Gastroenterology Outpatient Clinic, Sohag University Hospital

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal medicine resident

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 11, 2025
• Study Start: June 10, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 20, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06