Role of Ileoscopy in Diagnosis of ColitisNCT06371183
A Comparative Study of Clinical, Endoscopic and Histopathological Features of Colitis in Children
A study testing Colonoscope in people with Role of Ileoscopy in Diagnosis of Colitis, run by Assiut University.
Trial summary
A Comparative study of clinical, endoscopic and histopathological features of colitis in children Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Role of Ileoscopy in Diagnosis of Colitis
- What is being tested?
- Colonoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. All patients diagnosed as colitis during the study period. 2. Age from 1 month to 18 years.
Who cannot join
- Patients with lower gastrointestinal manifestations and weren't diagnosed as colitis during colonoscope.
- Patients less than one month and more than 18 years.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A Comparative study of clinical, endoscopic and histopathological features of colitis in children
Read the detailed description
To find out the role of ileoscopy in diagnosis of colitis and compare clinical , endoscopic and histopathological manifestations of colitis
- Being tested
- Colonoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopeDevice
Endoscopy for lower GIT
| Study group | Role | What they receive |
|---|---|---|
| Patients with lower GI manifestations | Other | Patients with lower GI manifestations will undergo total colonoscopy with biopsy Receives: Device: Colonoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is ileoscopy indicated for all children complaining of colitis on 196 patient
Biopsy from ileum will be taken to diagnose colitis
Measured: 2years
Secondary outcomes (1)
To correlate clinical manifestations by colonoscopic picture
Some patients with lower GI manifestations,their colonoscopy is normal. So corolate clinical with biopsy
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Role of Ileoscopy in Diagnosis of 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who complaining of lower GI manifestations
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Omar Mahmoud Said, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371183
- Sponsor's protocol ID
- AOMSaidB
- Status last verified
- Jul 2024
- First submitted
- 15 Apr 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will share the IPD results
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Clinical, Endoscopic and Histopathological Features of Colitis in Children
- ClinicalTrials.gov ID
- NCT06371183
- Acronym / sponsor ID
- AOMSaidB
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 17 Apr 2024 (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.
A Comparative study of clinical, endoscopic and histopathological features of colitis in children
Detailed description
To find out the role of ileoscopy in diagnosis of colitis and compare clinical , endoscopic and histopathological manifestations of colitis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who complaining of lower GI manifestations
| Arm | Type | Receives |
|---|---|---|
| Patients with lower GI manifestations | Other | Device: ColonoscopePatients with lower GI manifestations will undergo total colonoscopy with biopsy |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1. All patients diagnosed as colitis during the study period. 2. Age from 1 month to 18 years.
Key exclusion criteria (2 listed)
- Patients with lower gastrointestinal manifestations and weren't diagnosed as colitis during colonoscope.
- Patients less than one month and more than 18 years.
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 |
|---|---|---|
| ColonoscopeEndoscopy for lower GIT | Device | Patients with lower GI manifestations |
Primary outcome
Is ileoscopy indicated for all children complaining of colitis on 196 patient
Time frame: 2years
Biopsy from ileum will be taken to diagnose colitis
1 secondary outcome
To correlate clinical manifestations by colonoscopic picture
Time frame: 2years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Undecided. I will share the IPD results
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.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscope in people with Role of Ileoscopy in Diagnosis of 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 2 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: opening soon, as of the sponsor's last update on 16 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Omar, MD (01003337028, asmaaomar2749@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is ileoscopy indicated for all children complaining of colitis on 196 patient (time frame: 2years). 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 16 Jul 2024.