Chronic Diarrhea Owing to Underlying Microscopic Colitis

Chronic Diarrhea Owing to Underlying Microscopic Colitis: Diagnosis Challenges and Size of the Problem

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Diarrhea; Microscopic Colitis

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 44519
      • Zagazig university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presented with chronic diarrhea in the outpatient clinic or the inward in the Gastroenterology and Hepatology unit in the Internal Medicine Department, Zagazig University hospitals from January 2024 to January 2025

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Chronic Diarrhea Diagnosed with Microscopic Colitis	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Lymphocytic and Collagenous Types of Microscopic Colitis in Individuals Experiencing Chronic Diarrhea	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.	2 weeks

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Study Director: Ayman Sadek, MD, Associate Professor of Internal Medicine - Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): July 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: July 28, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Diarrhea; Colitis; Colitis, Microscopic
• Other Study ID Numbers: ZU-IRB#239/17-March-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No