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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05811091
Other study ID # Chronic diarrhea
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 5, 2024
Est. completion date May 5, 2024

Study information

Verified date March 2023
Source Assiut University
Contact Esraa Mansour Omar
Phone 01140285103
Email asramnswr82@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To asses prevalence of pathological findings in patients with chronic diarrhea and normal colonoscopy


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date May 5, 2024
Est. primary completion date March 6, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of pathological patterns in patients of chronic diarrhea with normal colonoscopy 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
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