Inflammatory Bowel DiseaseNCT05002166
Clinical Characteristics and Risk Factors of Children Suffering From Inflammatory Bowel Diseases At Assiut University Children Hospital
An observational study of Inflammatory Bowel Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Clinical Characteristics and Risk factors of Children Suffering from Inflammatory Bowel Diseases At Assiut University Children Hospital Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2021to 20 Jul 2027
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients admitted with inflammatory bowel disease
Who may be able to join
- Children aged less than 18 years with a confirmed diagnosis of IBD.
Who cannot join
- Children with colitis other than IBD or children with systemic diseases affecting GIT.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Christine zaghloul noos
Asyut, 23123
Christine Zaghloul, Resident, 01289132810, christinezaghloul@gmail.com
Shereen Mansour, Lecturer, 01003162310, Shyreen.ahmed@med.au.edu.eg
About this study
Clinical Characteristics and Risk factors of Children Suffering from Inflammatory Bowel Diseases At Assiut University Children Hospital
Read the detailed description
All patients admitted with inflammatory bowel disease will be subjected to:
- History: including name, age ,sex ,family history, consanguinity, history of rectal bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting ,nausea and loss of appetite.
- Examination: including general examination, chest, cardiac, abdominal and neurological examination
- Investigation:including labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.Other
labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.
| Study group | Role | What they receive |
|---|---|---|
| Children aged less than 18 years with a confirmed diagnosis of IBD. | All patients admitted with inflammatory bowel disease will be subjected to:
1. History: including name, age ,sex ,family history, consanguinity, history of rectal bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting ,nausea and loss of appetite.
2. Examination: including general examination, chest, cardiac, abdominal and neurological examination
3. Investigation:including labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope. Receives: Other: labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics and risk factors for IBD
To study the natural history, patterns, and clinical characteristics (as history of real bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting)and risk factors of inflammatory bowel diseases (IBD) at Assiut University Children Hospital
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start5 Aug 2021 (estimated)
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Zaghloul Noos, Assiut University
- Investigators
- Shereen Mansour, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002166
- Sponsor's protocol ID
- Infilamatory bowel disease
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Risk Factors of Children Suffering From Inflammatory Bowel Diseases At Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT05002166
- Acronym / sponsor ID
- Infilamatory bowel disease
- Conditions
- Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Aug 2021 (estimated)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 12 Aug 2021 (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.
Clinical Characteristics and Risk factors of Children Suffering from Inflammatory Bowel Diseases At Assiut University Children Hospital
Detailed description
All patients admitted with inflammatory bowel disease will be subjected to:
- History: including name, age ,sex ,family history, consanguinity, history of rectal bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting ,nausea and loss of appetite.
- Examination: including general examination, chest, cardiac, abdominal and neurological examination
- Investigation:including labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children aged less than 18 years with a confirmed diagnosis of IBD. | – | Other: labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.All patients admitted with inflammatory bowel disease will be subjected to: 1. History: including name, age ,sex ,family history, consanguinity, history of rectal bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting ,nausea and loss of appetite. 2. Examination: including general examination, chest, cardiac, abdominal and neurological examination 3. Investigation:including labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients admitted with inflammatory bowel disease
Key inclusion criteria (1 listed)
- Children aged less than 18 years with a confirmed diagnosis of IBD.
Key exclusion criteria (1 listed)
- Children with colitis other than IBD or children with systemic diseases affecting GIT.
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 |
|---|---|---|
| labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope. | Other | Children aged less than 18 years with a confirmed diagnosis of IBD. |
Primary outcome
Clinical characteristics and risk factors for IBD
Time frame: 6 months
To study the natural history, patterns, and clinical characteristics (as history of real bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting)and risk factors of inflammatory bowel diseases (IBD) at Assiut University Children Hospital
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 12 Aug 2021.
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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.
Shereen Mansour, Lecturer principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Assiut University at 1 site in Egypt.
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 1 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: looking for participants now, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Christine Zaghloul, Resident (01289132810, christinezaghloul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characteristics and risk factors for IBD (time frame: 6 months). 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 12 Aug 2021.