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CompletedNCT06530836Updated Sep 4, 2026

Chronic Diarrhea Owing to Underlying Microscopic Colitis

An observational study in Chronic Diarrhea and Microscopic Colitis, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Zagazig University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
116
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Chronic Diarrhea
  • Microscopic Colitis

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Inclusion criteria

  • Patients with chronic watery diarrhea

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
116 participants (actual)
Patient registry
No
05

What researchers measure

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.

    Time frame: 6 weeks

Secondary outcomes

  1. 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.

    Time frame: 2 weeks

06

Study locations

1 site
  • Zagazig University Hospital
    Zagazig, Sharqia Province 44519, Egypt
07

Registry details

Key details

Study ID
NCT06530836
Lead sponsor
Zagazig University
Responsible party
Ayman Magd Eldin Mohammad Sadek (Associate Professor of Internal Medicine, Zagazig University) — Principal investigator
First posted
Jul 31, 2024
Start date
Jan 1, 2024
Primary completion
Jul 1, 2024
Completion
Jan 1, 2025
Last update
Sep 4, 2026

Study contacts

Ayman Sadek, MD
study director · Associate Professor of Internal Medicine - Zagazig University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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