Primary Eosinophilic Colitis in Symptomatic Patients.

February 9, 2023 updated by: Marwa M.Abokresha, Assiut University

Prevalence and Clinicopathologic Pattern of Primary Eosinophilic Colitis in Symptomatic Patients.

The aim of the present study was to know the prevalence of primary eosinophilic colitis(PEC) in patients with lower gastrointestinal symptoms including diarrhea and chronic abdominal pain for which no other causes were identified.

Study Overview

Status

Not yet recruiting

Conditions

Eosinophilic Colitis

Intervention / Treatment

Diagnostic test: colonoscopy

Detailed Description

The presence of eosinophils in the different segments of the digestive tract is common and seen in diverse clinical scenarios. Eosinophilic gastrointestinal diseases (EGIDs) are a group of disorders characterized by symptoms of gastrointestinal dysfunction, caused by the inflammatory infiltration of eosinophils and include eosinophilic esophagi-tis, eosinophilic gastroenteritis, and eosinophilic colitis.

Primary eosinophilic colitis (PEC) is defined as an inflammatory disease of unknown etiology that mainly manifests as abdominal pain and diarrhea, segmental or diffuse infiltration of eosinophils in the mucosa of the colon, for which other possible causes have been ruled out .

The usual endoscopic findings tend to be nonspecific, and even though PEC is considered a rare disease, its prevalence is unknown. Evaluation of the colonic mucosa is very helpful in detecting inflammatory bowel disease, ischemic colitis, microscopic colitis ,neoplasia, 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 undetected

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: marwa M abokresha, MD
Phone Number: 01000580208
Email: marwainternalmedicine@gmail.com

Study Contact Backup

Name: marwa M abokresha, MD
Phone Number: 0100580208
Email: marwainternalmedicine@gmail.com

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients will be subjected to :

Detailed history, clinical examination
Laboratory tests :
I-CBC, ESR or CRP or both, ,complete stool analysis . II- Fecal occult blood, fecal calprotectin when indicated in selected patients. III- Autoimmune antibody including ANA,antiDNA ,ANCA,ASCA when indicated in selected patients .
CT imaging when indicated
COLONOSCOPY examination :

All patients underwent colonoscopy with random biopsies of all the colonic segments (at least 10 biop-sies per study,even in the presence of normal-appearing mucosa, and had biopsies of the segments with minimal alterations (areas oferythema, with hemorrhagic spots, loss of vascular pattern,and a nodular appearance, among others) At El-Raghy colonoscopy unit , Assuit university hospital

Description

Inclusion Criteria:

All in- patients and out- patients above 18 y old undergo colonoscopy unit in Al Raghy hospital with unexplained lower symptoms including abdominal pain ,diarrhea, IBS predominant diarrhea, between , between February 2023 and December 2024 and

Exclusion Criteria:

Cases diagnosed with 2ry causes for colonic eosinophilia.
Patients with a known or compensated organic disease associated with diarrhea and alarm features (e.g., involuntary weight loss > 10% of the baseline weight, within the past 6 months.
Patients with anemia, cancer and history of organ transplantation.
Patients with HIV-AIDS infection.
Patients under regular treatment with clozapine, carba-mazepine, rifampin, tacrolimus, gold salts, or non steroidal anti-inflammatory drugs, for 6 months prior to disease onset.
Patients contraindicated for colonoscopy or biopsy, and patients with incomplete colonoscopy or inadequate bowel cleanliness at the time of the study .

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 PEC in patients with lower gastrointestinal symptoms including diarrhea and chronic abdominal pain for which no other causes were identified. Time Frame: Baseline	Estimation the prevalence of eosinophilic colitis	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

Study Director: Hussein A elamin, MD, Pro. Internal medicine and gastroentrology and hepatology unit
Study Chair: Hyam Fathy, MD, consultant of internal medicine gastroentrology and hepatology unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2023

Primary Completion (ANTICIPATED)

October 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria