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Active, Not Recruiting

NCT Number: NCT06530836

Chronic Diarrhea Owing to Underlying Microscopic Colitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zagazig University Hospital

Zagazig, Sharqia Province, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants with Chronic Diarrhea Diagnosed with Microscopic Colitis

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 31, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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