Inflammatory Bowel DiseasesNCT03172000
Detection of Helicobacter Pylori in Ulcerative Colitis Patients
A study testing Colonoscopy and biopsy in people with Inflammatory Bowel Diseases, run by Tanta University at 1 site in Egypt.
Trial summary
Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases in humans. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Colonoscopy and biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to Dec 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- newly diagnosed ulcerative colitis
Who cannot join
- Other diagnosis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university - faculty of medicine
Cairo
Sherief M Abdelsalam, lecturer, 00201095159522, Sheriefabdelsalam@yahoo.com
About this study
Official title: Detection of Helicobacter Pylori in Colonic Tissue in Newly Diagnosed Ulcerative Colitis Patients
Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases in humans.
Read the detailed description
Several bacterial and viral agents may have a role in the aetiology of IBD. In theory, H. pylori infection could be involved in IBD by inducing alterations in gastric and/or intestinal permeability or by causing immunological derangements resulting in absorption of antigenic material and autoimmunity via various immunological pathways.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Colonoscopy and biopsy
- 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.
Colonoscopy and biopsyDiagnostic test
Colonoscopic biopsy were taken from the rectum, the sigmoid, descending, transverse, ascending colon, and the cecum of each patient.
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy and biopsy | Active comparator | IBD patients Receives: Diagnostic Test: Colonoscopy and biopsy |
| Colonoscopic biopsy | No intervention | Non IBD patients colonoscopic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Helicobacter
Number of patients with Helicobacter
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 posted31 May 2017
- Study start1 Mar 2017
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loai Mansour, MD, Principal investigator, Tanta University Faculty of MedicineFerial El-kalla, MD, Principal investigator, Tanta university Faculty of MedicineAbdelrahman Kobtan, MD, Study director, Tanta University Faculty of MedicineHanan Soliman, MD, Study director, Tanta University Faculty of MedicineSherief Abd-Elsalam, MD, Study chair, Tanta University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172000
- Sponsor's protocol ID
- IBD Helicobacter
- Status last verified
- May 2017
- First submitted
- 27 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Helicobacter Pylori in Colonic Tissue in Newly Diagnosed Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT03172000
- Acronym / sponsor ID
- IBD Helicobacter
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 31 May 2017 (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.
Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases in humans.
Detailed description
Several bacterial and viral agents may have a role in the aetiology of IBD. In theory, H. pylori infection could be involved in IBD by inducing alterations in gastric and/or intestinal permeability or by causing immunological derangements resulting in absorption of antigenic material and autoimmunity via various immunological pathways.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy and biopsy | Active comparator | Diagnostic Test: Colonoscopy and biopsyIBD patients |
| Colonoscopic biopsy | No intervention | –Non IBD patients colonoscopic biopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- newly diagnosed ulcerative colitis
Key exclusion criteria (1 listed)
- Other diagnosis
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 |
|---|---|---|
| Colonoscopy and biopsyColonoscopic biopsy were taken from the rectum, the sigmoid, descending, transverse, ascending colon, and the cecum of each patient. | Diagnostic test | Colonoscopy and biopsy |
Primary outcome
Number of patients with Helicobacter
Time frame: 6 months
Number of patients with Helicobacter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
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.
Loai Mansour, MD principal investigator
Tanta University Faculty of Medicine
Ferial El-kalla, MD principal investigator
Tanta university Faculty of Medicine
Abdelrahman Kobtan, MD study director
Tanta University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy and biopsy in people with Inflammatory Bowel Diseases, run by Tanta 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: status not confirmed, as of the sponsor's last update on 31 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, MD (00201147773440, Sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Helicobacter (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 31 May 2017.