Chronic Diarrhea Owing to Underlying Microscopic Colitis

NCT06530836 | Active Not Recruiting

• 1 other identifier: ZU-IRB#239/17-March-2024
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Diarrhea; Microscopic Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of Lymphocytic and Collagenous Types of Microscopic Colitis in Individuals Experiencing Chronic Diarrhea

  2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with chronic watery diarrhea

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospital

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Colitis, Microscopic

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ayman Sadek, MD

  Associate Professor of Internal Medicine - Zagazig University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

EG (1)