Primary Eosinophilic Colitis in Symptomatic Patients.

Eosinophilic Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05719727
• Other study ID #: Esinophilic colitis
• Status: Not yet recruiting
• Start date: February 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2023
• Source: Assiut University
• Contact: marwa M abokresha, MD
• Phone: 01000580208
• Email: marwainternalmedicine[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Colitis
• Eosinophilic Colitis

Intervention

Diagnostic Test:
• colonoscopy
lower colonoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Egan M, Furuta GT. Eosinophilic gastrointestinal diseases beyond eosinophilic esophagitis. Ann Allergy Asthma Immunol. 2018 Aug;121(2):162-167. doi: 10.1016/j.anai.2018.06.013. Epub 2018 Jun 22. — View Citation

Impellizzeri G, Marasco G, Eusebi LH, Salfi N, Bazzoli F, Zagari RM. Eosinophilic colitis: A clinical review. Dig Liver Dis. 2019 Jun;51(6):769-773. doi: 10.1016/j.dld.2019.04.011. Epub 2019 May 20. — View Citation

Villanueva MS, Alimi Y. Microscopic colitis (lymphocytic and collagenous), eosinophilic colitis, and celiac disease. Clin Colon Rectal Surg. 2015 Jun;28(2):118-26. doi: 10.1055/s-0035-1549365. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of PEC in patients with lower gastrointestinal symptoms including diarrhea and chronic abdominal pain for which no other causes were identified.	Estimation the prevalence of eosinophilic colitis	Baseline