NCT05719727

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

January 31, 2023

Last Update Submit

February 9, 2023

Conditions

Eosinophilic Colitis

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

colonoscopyDIAGNOSTIC_TEST

lower colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients will be subjected to : 1. Detailed history, clinical examination 2. 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 . 3. CT imaging when indicated 4. 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

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 29940308RESULT

  • 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.

    PMID: 26034409RESULT

  • 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.

    PMID: 31122823RESULT

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Hussein A elamin, MD

    Pro. Internal medicine and gastroentrology and hepatology unit

    STUDY DIRECTOR

  • Hyam Fathy, MD

    consultant of internal medicine gastroentrology and hepatology unit

    STUDY CHAIR

Central Study Contacts

marwa M abokresha, MD

CONTACT

01000580208marwainternalmedicine@gmail.com

marwa M abokresha, MD

CONTACT

0100580208marwainternalmedicine@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of gastroenterology and hepatology

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

February 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

February 10, 2023

Record last verified: 2023-02