Pathological Patterns in Chronic Diarrhea With Normal Colonoscopy

NCT ID: NCT05811091

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-05

Study Completion Date

2024-05-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Diarrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Esraa Mansour Omar

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Esraa Mansour Omar

Role: CONTACT

01140285103 ext. 01030954853

Hossam Abdel Wahab, Prof

Role: CONTACT

01146539976

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Chronic diarrhea

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.