- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05811091
Pathological Patterns in Chronic Diarrhea With Normal Colonoscopy
March 31, 2023 updated by: Esraa Mansour Omar, Assiut University
Prevalence of Pathological Patterns in Patients of Chronic Diarrhea With Normal Colonoscopy
To asses prevalence of pathological findings in patients with chronic diarrhea and normal colonoscopy
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
diarrhea is defined as the of 3 or more loose or liquid stools per day, or more frequently than is normal for the individual.
3. (World Health ion.
Diarrhoeal disease .Available 2017) Diarrhea can be separated into acute, persistent and chronic types based on duration.
Acute diarrhea lasts less than 14 days whereas persistent diarrhea is longer than 14 days, but no longer than 28 days( Zilla GC, Israel EJ. et al ..2012) Chronic diarrhea than 28 days.
(Schiller LR, Parda DS, et al..2017) In addition to duration of symptoms, chronic diarrhea also tends to occur without a clear onset whereas persistent diarrhea can be thought of as an acute process that has persisted for a longer period.(
zilla GC, Israel EJ. et al ..2012) it can be secondary to such heterogeneous causes as drug side effects, structural abnormalities of the small bowel and/or colon, the result of previous gastrointestinal surgery, inflammatory or neo-plastic pancreato biliary disease, or as part of an intestinal functional disorder, such as functional diarrhea, or irritable bowel syndrome (IBS) that is diarrhea predominant (IBS-D)or post infectious (PI-IBS) ( Burgers K, Lindberg B, 2020) or Primary eosinophilic colitis (PEC) is defined as an inflam-matory disease of unknown etiology that mainly manifests as abdominal pain and diarrhea, segmental or diffuse infil-tration of eosinophils in the mucosa of the colon,( Villanueva MS, Alimi Y.et al ..2015)( Impellizzeri G, Marasco G ,et al ..2019) or Enteropathies( are diseases that affect small bowel (SB) function and clinically manifest as chronic diarrhea).(
Jansson-Knodell CL, Hujoel IA, et al 2017) as Monomorphic epitheliotropic intestinal T-cell lymphoma(MEITL) is a rare aggressive disease that mainly affects the SuB mucosa.
Its symptoms can be nonspecific, but often presents chronic diarrhea (Ramírez-Quintero JD, Carvajal JJ,et al..2021) Evaluation of the colonic mucosa is very helpful in detecting inflam-matory bowel disease, ischemic colitis, microscopic colitis, neoplasis, and intraepithelial infections.
The endoscopic appearance of the colon is normal, or almost normal, in some of those diseases, and thus they can go by un detected .Different studies have shown that systematic endoscopic biopsies of the colon provide good diagnostic yield in patients with chronic non inflammatory diarrhea and normal colonoscopy (López-Valenzuela LA, Murcio-Pérez E, et al..2019) chronic inflammatory disorder of the large intestine that mainly affects the elderly.
Microscopic colitis differs from classical inflammatory bowel disease (IBD) in its almost normal-appearing colonic mucosa and histological findings consistent with increased lymphocytic infiltrates with or without collagen fiber expansion (Khalili et al., 2020).
Microscopic colitis has two major subtypes, lymphocytic colitis (LC) and collagenous colitis (CC) (Shor et al., 2019) chronic watery diarrhea and often have no weight loss These forms of colitis also have an entirely of normal endoscopic appearance (Macaigne et al., 2014).
If colonoscopy is done in patients suspected of having IBS-D, random colon biopsies should be done to rule out , structural abnormalities of the small bowel and/or colon, the result of previous gastrointestinal surgery, inflammatory or neo-plastic pancreato biliary disease, or as part of an intestinal functional disorder, such as functional diarrhea, or irritable bowel syndrome (IBS) that is diarrhea predominant (IBS-D)or post infectious (PI-IBS) ( Burgers K, Lindberg B, 2020) or Primary eosinophilic colitis and microscopic colitis (Münch et al., 2020).
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Esraa Mansour Omar
- Phone Number: 01030954853 01140285103
- Email: asramnswr82@gmail.com
Study Contact Backup
- Name: Hossam Abdel Wahab, Prof
- Phone Number: 01146539976
- Email: h.mahmoud@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
All patients from 18 to 75 years presented to out patient clinic in Elraghi hospital in Assuit university with chronic diarrhea and normal colonoscopy
Description
Inclusion Criteria:
- all patients with chronic diarrhea and had normal colonoscopy
Exclusion Criteria:
- Inflammatory bowel diseases (ulcerative colitis, crohns 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 due to decreased digestion as in pancreatic insufficiency,bile acid deficiency and Infectious colitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of pathological patterns in patients of chronic diarrhea with normal colonoscopy
Time Frame: 1year
|
As number of patients who has chronic diarrhea and thier colonoscopy was normal we need to know pathological pattern in thier biopsies if esinophilic or lymphcytic and either
|
1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 5, 2024
Primary Completion (Anticipated)
March 6, 2024
Study Completion (Anticipated)
May 5, 2024
Study Registration Dates
First Submitted
March 16, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Estimate)
April 13, 2023
Study Record Updates
Last Update Posted (Estimate)
April 13, 2023
Last Update Submitted That Met QC Criteria
March 31, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chronic diarrhea
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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