Chronic DiarrheaNCT06530836
Chronic Diarrhea Owing to Underlying Microscopic Colitis
An observational study of Chronic Diarrhea and Microscopic Colitis, run by Zagazig University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Diarrhea, Microscopic Colitis
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with chronic watery diarrhea
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Diarrhea, Microscopic Colitis
- Medical subject headings
- Colitis, Microscopic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jan 2024
- Primary completion1 Jul 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayman Magd Eldin Mohammad Sadek, Zagazig University
- Investigators
- Ayman Sadek, MD, Study director, Associate Professor of Internal Medicine - Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530836
- Sponsor's protocol ID
- ZU-IRB#239/17-March-2024
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Diarrhea Owing to Underlying Microscopic Colitis: Diagnosis Challenges and Size of the Problem
- ClinicalTrials.gov ID
- NCT06530836
- Acronym / sponsor ID
- ZU-IRB#239/17-March-2024
- Conditions
- Chronic Diarrhea, Microscopic Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with chronic watery diarrhea
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Rate of Lymphocytic and Collagenous Types of Microscopic Colitis in Individuals Experiencing Chronic Diarrhea
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Related trials for Chronic Diarrhea
RecruitingEarly Phase 1
ND-12 Combined With H-6 for Adult Chronic Inflammatory Diarrhea
Diarrhea Chronic, UC - Ulcerative Colitis
RecruitingObservational study
Chronic Loose Stools Following Right-sided Hemicolectomy for Colon Cancer and the Association With Bile Acid Malabsorption and Small Intestinal Bacterial Overgrowth Using a Novel Sampling Device
Colon Cancer
Recruiting
Repeated Transcranial Magnetic Stimulation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Clinical Trial
Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea (IBS-D)
Active, not recruiting
Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis
Diarrhea, Systemic Sclerosis
RecruitingObservational study
Development of New Diagnostic Tools in Capsule Endoscopy
Bowel Disease, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Sadek, MD study director
Associate Professor of Internal Medicine - Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Diarrhea and Microscopic Colitis, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Chronic Diarrhea Diagnosed with Microscopic Colitis (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.