Eosinophilic ColitisNCT05719727
Primary Eosinophilic Colitis in Symptomatic Patients.
An observational study of Eosinophilic Colitis, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Colitis
- What is being tested?
- colonoscopy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Dec 2024
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Conditions
- Eosinophilic Colitis
- Being tested
- colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyDiagnostic test
lower colonoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic ColitisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa M.Abokresha, Assiut University
- Investigators
- Hussein A elamin, MD, Study director, Pro. Internal medicine and gastroentrology and hepatology unitHyam Fathy, MD, Study chair, consultant of internal medicine gastroentrology and hepatology unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719727
- Sponsor's protocol ID
- Esinophilic colitis
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29940308Villanueva 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.
PubMed 26034409Impellizzeri 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.
PubMed 31122823
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinicopathologic Pattern of Primary Eosinophilic Colitis in Symptomatic Patients.
- ClinicalTrials.gov ID
- NCT05719727
- Acronym / sponsor ID
- Esinophilic colitis
- Conditions
- Eosinophilic Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Feb 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopylower colonoscopy | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Results publication: PubMed 29940308Egan 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.
- Results publication: PubMed 26034409Villanueva 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.
- Results publication: PubMed 31122823Impellizzeri 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.
- Individual participant dataSharing planned: Undecided
Related trials for Eosinophilic Colitis
Active, not recruitingPhase 2
A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))
Colitis Ulcerative
RecruitingObservational study
Eosinophilic Gastrointestinal Disorders Registry
Eosinophilic Esophagitis, Eosinophilic Gastroenteritis
RecruitingObservational study
OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis
RecruitingObservational study
National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders
Eosinophilic Gastrointestinal Disorders, Eosinophilic Esophagitis
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.
Hussein A elamin, MD study director
Pro. Internal medicine and gastroentrology and hepatology unit
Hyam Fathy, MD study chair
consultant of internal medicine gastroentrology and hepatology unit
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Colitis, 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 6 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 10 Feb 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 marwa M abokresha, MD (01000580208, marwainternalmedicine@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05719727, which also lists 3 linked publications.
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 10 Feb 2023.