Inflammatory Bowel DiseasesNCT04708405
The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation
An observational study of Inflammatory Bowel Diseases and Helicobacter Pylori Infection, run by Alexandria University at 1 site in Egypt.
Trial summary
Numerous epidemiological studies have investigated the association between Helicobacter pylori (H. pylori) infection and inflammatory bowel disease (IBD) with various conflicting results. The main objective of this study is to further explore the possible association between H. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Helicobacter Pylori Infection
- What is being tested?
- Observation
- How many people
- 182 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2019to 30 Oct 2020
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patients diagnosed with inflammatory bowel disease condition
Who may be able to join
- Diagnosed with inflammatory bowel disease condition
Who cannot join
- Having irritable bowel disease
- Being younger than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Numerous epidemiological studies have investigated the association between Helicobacter pylori (H. pylori) infection and inflammatory bowel disease (IBD) with various conflicting results. The main objective of this study is to further explore the possible association between H. pylori infection and IBD and its impact on disease course. The investigators sought to conduct a prospective observational study and enroll a total of 182 IBD patients who were screened for H. pylori infection. All the participants will be clinically evaluated at the initial visit and bimonthly for 3 months. Several factors will be explored such are diet, physical activity, life style and considering specific environmental exposures that impact the development of disease or its relapse.
- Being tested
- Observation
- Keywords
- Inflammatory Bowel Diseases, Helicobacter Pylori, Egypt
- 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.
ObservationOther
Follow up and observe under standard of care given
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory bowel disease patients | Inflammatory bowel disease patients screened for Helicobacter Pylori Infection Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the inflammatory bowel disease condition
Change in the inflammatory bowel disease condition during follow up as measured by disease related symptoms [weight loss where weight will be measured and reported in kilograms]
Measured: 3 months
Change in the inflammatory bowel disease condition
Change in the inflammatory bowel disease condition during follow up as measured by frequency of disease related symptoms [number of attacks disease related symptoms per day (diarrhea, tenesmus, bleeding per rectum, abdominal pain, indigestion)]
Measured: 3 months
Change in the inflammatory bowel disease condition
Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [C reactive protein (IU/ml)]
Measured: 3 months
Change in the inflammatory bowel disease condition
Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [Hemoglobin (g/dl)]
Measured: 3 months
Change in the inflammatory bowel disease condition
Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in blood samples [Complete blood picture including white blood count per cmm, platelets count per cmm]
Measured: 3 months
Change in the inflammatory bowel disease condition
Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [ESR (mm/hr)]
Measured: 3 months
Change in the inflammatory bowel disease condition
Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [Fasting blood glucose (mg/dl)]
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start10 Sep 2019
- Primary completion10 Oct 2020
- Study completion30 Oct 2020
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 Alexandria 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- High Institute of Public Health, Egypt
- Responsible party
- Principal investigator, Ekram Abdel Wahab, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708405
- Sponsor's protocol ID
- 622-2019
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation
- ClinicalTrials.gov ID
- NCT04708405
- Acronym / sponsor ID
- 622-2019
- Keywords
- Inflammatory Bowel Diseases, Helicobacter Pylori, Egypt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- High Institute of Public Health, Egypt
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 14 Jan 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.
Numerous epidemiological studies have investigated the association between Helicobacter pylori (H. pylori) infection and inflammatory bowel disease (IBD) with various conflicting results. The main objective of this study is to further explore the possible association between H. pylori infection and IBD and its impact on disease course. The investigators sought to conduct a prospective observational study and enroll a total of 182 IBD patients who were screened for H. pylori infection. All the participants will be clinically evaluated at the initial visit and bimonthly for 3 months. Several factors will be explored such are diet, physical activity, life style and considering specific environmental exposures that impact the development of disease or its relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory bowel disease patients | – | Other: ObservationInflammatory bowel disease patients screened for Helicobacter Pylori Infection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients diagnosed with inflammatory bowel disease condition
Key inclusion criteria (1 listed)
- Diagnosed with inflammatory bowel disease condition
Key exclusion criteria (2 listed)
- Having irritable bowel disease
- Being younger 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 |
|---|---|---|
| ObservationFollow up and observe under standard of care given | Other | Inflammatory bowel disease patients |
Primary outcome
Change in the inflammatory bowel disease condition
Time frame: 3 months
Change in the inflammatory bowel disease condition during follow up as measured by disease related symptoms [weight loss where weight will be measured and reported in kilograms]
Change in the inflammatory bowel disease condition
Time frame: 3 months
Change in the inflammatory bowel disease condition during follow up as measured by frequency of disease related symptoms [number of attacks disease related symptoms per day (diarrhea, tenesmus, bleeding per rectum, abdominal pain, indigestion)]
Change in the inflammatory bowel disease condition
Time frame: 3 months
Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [C reactive protein (IU/ml)]
Change in the inflammatory bowel disease condition
Time frame: 3 months
Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [Hemoglobin (g/dl)]
Change in the inflammatory bowel disease condition
Time frame: 3 months
Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in blood samples [Complete blood picture including white blood count per cmm, platelets count per cmm]
Change in the inflammatory bowel disease condition
Time frame: 3 months
Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [ESR (mm/hr)]
Change in the inflammatory bowel disease condition
Time frame: 3 months
Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [Fasting blood glucose (mg/dl)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: Undecided. publication
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Diseases and Helicobacter Pylori Infection, run by Alexandria 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 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: finished, as of the sponsor's last update on 15 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the inflammatory bowel disease condition (time frame: 3 months). The study lists 7 primary outcomes in all. 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 15 Jan 2021.