Chronic DiarrheaNCT05811091
Pathological Patterns in Chronic Diarrhea With Normal Colonoscopy
An observational study of Chronic Diarrhea, run by Assiut University.
Trial summary
To asses prevalence of pathological findings in patients with chronic diarrhea and normal colonoscopy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Diarrhea
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2024to 5 May 2024
- 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 to 75 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- all patients with chronic diarrhea and had normal colonoscopy
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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).
- Conditions
- Chronic Diarrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start5 Mar 2024 (estimated)
- Primary completion6 Mar 2024 (estimated)
- Study completion5 May 2024 (estimated)
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mansour Omar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811091
- Sponsor's protocol ID
- Chronic diarrhea
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Pathological Patterns in Patients of Chronic Diarrhea With Normal Colonoscopy
- ClinicalTrials.gov ID
- NCT05811091
- Acronym / sponsor ID
- Chronic diarrhea
- Conditions
- Chronic Diarrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Mar 2024 (estimated)
- Primary completion
- 6 Mar 2024 (estimated)
- Study completion
- 5 May 2024 (estimated)
- First posted
- 13 Apr 2023 (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.
To asses prevalence of pathological findings in patients with chronic diarrhea and normal colonoscopy
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- all patients with chronic diarrhea and had normal colonoscopy
Key exclusion criteria (4 listed)
- 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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Diarrhea, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Mansour Omar (01140285103 ext. 01030954853, asramnswr82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of pathological patterns in patients of chronic diarrhea with normal colonoscopy (time frame: 1year). 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 13 Apr 2023; AzTrials last refreshed its copy on 27 Oct 2026.