Chronic Diarrhea Owing to Underlying Microscopic Colitis

Active, not recruiting

• Conditions: Chronic Diarrhea; Microscopic Colitis

• Registration Number: NCT06530836
• Lead Sponsor: Zagazig University

Brief Summary

The goal of this observational study is to search for accurate diagnoses for patients with chronic diarrhea and assess the prevalence of microscopic colitis. The main question\[s\] it aims to answer \[is/are\]:

Does microscopic colitis account for a significant portion of patients with chronic diarrhea?

Participants will subjected to:

* Routine laboratory examination.

* Colonoscopy: A total colonoscopy will be done with visualization of the terminal ileum. Biopsies will be taken from each segment of the colon and any abnormal appearing areas, the right-sided colon (cecum, ascending colon, and transverse colon), the left-sided colon (descending colon and sigmoid colon), and the rectum.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-07
• Primary Completion: 2024-07-01
• Study First Submitted: 2024-07-28
• Study First Submitted QC: 2024-07-28
• Study First Posted: 2024-07-31
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Patients with chronic watery diarrhea

Exclusion Criteria

• Infectious colitis.
• Inflammatory bowel diseases (ulcerative colitis, Crohn's disease, and indeterminate colitis).
• Systemic disease associated with chronic diarrhea, e.g. Diabetes mellitus and Thyroid disease.
• Drugs causing chronic diarrhea, e.g. antibiotics, antidepressants, and angiotensin-converting enzyme inhibitors.
• Chronic diarrhea of decreased digestion as in pancreatic insufficiency and bile acid deficiency.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Chronic Diarrhea Diagnosed with Microscopic Colitis	6 weeks	Diagnostic criteria for the diagnosis of microscopic colitis include increased chronic inflammatory infiltration in the lamina propria, increased intraepithelial lymphocytes (IELs), degeneration of surface epithelium, and increased mitosis in crypts.

Secondary Outcome Measures

Name	Time	Method
Rate of Lymphocytic and Collagenous Types of Microscopic Colitis in Individuals Experiencing Chronic Diarrhea	2 weeks	Over 20 IELs per 100 inter-cryptal epithelial cells (normal \<1-5/100) were required for the diagnosis of lymphocytic colitis.; For collagenous colitis, subepithelial collagen band thickness was measured by ocular micrometer in specimens stained with Masson's Trichrome. Specimen thickness over 10 μm was required for the diagnosis.

Trial Locations

Locations (1)

Zagazig University Hospital; 🇪🇬 Zagazig, Sharkia, Egypt