Helicobacter InfectionsNCT03820284
Association Between Helicobacter Pylori and Inflammatory Bowel Disease
An observational study of Helicobacter Infections, run by Assiut University at 1 site in Egypt.
Trial summary
Introduction: Helicobacter pylori has been linked to a variety of gastric and extra gastric diseases. Chronic infection with H. pylori causes histologically evident gastritis in all colonized individuals and is the predominant risk factor for gastric and duodenal ulcers as well as gastric adenocarcinoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Helicobacter Infections
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inflammatory bowel disease patients with or without H.pylori infection
Who may be able to join
- all inflammatory bowel disease at assiut university will be included and examined in cross sectional study for detection of presence of H.pylori in one year 2019-2020 .then the examined patients will be divided in two group A ,B according to presence or absence of H pylori . Both group will be studied in cohort study for two years
Who cannot join
- -patients with history of administration of proton pump inhibitor or antibiotics with in eight weeks .
- patients with history of recent upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Introduction:
Helicobacter pylori has been linked to a variety of gastric and extra gastric diseases. Chronic infection with H. pylori causes histologically evident gastritis in all colonized individuals and is the predominant risk factor for gastric and duodenal ulcers as well as gastric adenocarcinoma. However, increasingly robust experimental and epidemiological evidence suggests that H. pylori may at the same time be beneficial to its carriers, as it efficiently prevents allergic disorders and chronic inflammatory conditions .
Read more
Inflammatory bowel disease (IBD) is characterized by chronic, nonspecific intestinal inflammation with an unexplained pathology and an alternating relapsing and remitting clinical progression. IBD is divided into two subtypes: ulcerative colitis (UC) and Crohn's disease (CD). Most studies in the IBD field attribute its etiology to the complex interactions among immune dysfunction, genetic susceptibility of the host, and environmental risk factors.
Since the twenty-first century, improving hygienic conditions and socioeconomic status have reduced the H. pylori infection rate and this trend has concurrently been accompanied by an increased IBD incidence in most countries Numerous studies have reported a lower H. pylori infection rate in patients with CD and/or UC than in non-IBD control individuals. although a small number of studies showed no significant association .Recently, emerging epidemiologic studies and animal experiments revealed an inverse correlation between H. pylori infection and IBD onset, suggesting that H. pylori colonization exerts a special protective effect on autoimmune diseases
observation Cross sectional study will be conducted at assuit university hospitals on all patients with inflammatory disease to detect the prevalence of helicobacter pylori among them .Then the examined patients will be divided in to two group receiving the same medication group A : inflammatory bowel disease patient with H.PYLORI group B: inflammatory bowel disease Patient without H.PYLORI longitudinal study will be conducted to both group to study the clinical outcomes in both group .
Read the detailed description
PATIENT AND METHOD :
observation Cross sectional study will be conducted at assuit university hospitals on all patients with inflammatory disease to detect the prevalence of helicobacter pylori among them .Then the examined patients will be divided in to two group receiving the same medication group A : inflammatory bowel disease patient with H.PYLORI group B: inflammatory bowel disease Patient without H.PYLORI longitudinal study will be conducted to both group to study the clinical outcomes in both group .
- Thorough medical history and full clinical examination will be taken from all patient including -Personal history focus on special habit especially smoking -documented previous history for H.pylori eradication
- Onset and duration of inflammatory bowel disease
- current medication
- presence of any extra intestinal manifestation of Inflammatory bowel disease
- presence of any complications from Inflammatory bowel disease
- Investigation : -All patients with inflammatory bowel disease will be tested for presence or absence of H.PYLORI by histological examination of endoscopically biopsied gastric mucosa -his to logical examination of colonic mucosal every 3 months -complete blood count -serum albumin -c reactive protein, erythrocyte sedimentation rate (ESR). -fecal calprotectin if possible
- assess the severity of among both group (A,B) every 3 month for 2years. ulcerative by Mayo Score/Ulcerative Colitis Disease Activity Index and Crohn's disease by Montreal classifications for Crohn's Disease . Mayo Score/Ulcerative Colitis Disease Activity Stool frequency 0 = Normal 1 = 1-2 stools/day more than normal 2 = 3-4 stools/day more than normal 3 = 4 stools/day more than normal Rectal bleeding 0 = None 1 = Visible blood with stool less than half the time 2 = Visible blood with stool half of the time or more 3 = Passing blood alone Mucosal appearance at endoscopy 0 = Normal or inactive disease 1 = Mild disease (erythema, decreased vascular pattern, mild friability) 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions) 3 = Severe disease (spontaneous bleeding, ulceration) Physician rating of disease activity 0 = Normal 1 = Mild 2 = Moderate 3 = Severe
- Conditions
- Helicobacter Infections
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A inflammatory bowel disease with helicobacter pylori infection | |
| Group B | Inflammatory bowel disease without helicobacter pylori infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalance of H.pylori among patients with inflammatory bowel disease
Number of patient with inflammatory bowel disease with H.pylori infection
Measured: One years
Mayo score activity index among ulcerative colitis patients with H.pylori and without H.pylori
Stool frequency 0 = Normal 1 = 1-2 stools/day more than normal 2 = 3-4 stools/day more than normal 3 = 4 stools/day more than normal Rectal bleeding 0 = None 1 = Visible blood with stool less than half the time 2 = Visible blood with stool half of the time or more 3 = Passing blood alone Mucosal appearance at endoscopy 0 = Normal or inactive disease 1 = Mild disease (erythema, decreased vascular pattern, mild friability) 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions) 3 = Severe disease (spontaneous bleeding, ulceration) Physician rating of disease activity 0 = Normal 1 = Mild 2 = Moderate 3 = Severe
Measured: Two years
Mucosal healing among inflammatory bowel disease with H.pylori and without H.pylori
Histological examination of the biopsied colonic mucosal every 3 months in both groups
Measured: 1years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Feb 2019
- Primary completion1 Feb 2019
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter InfectionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaa osman taha, Assiut University
- Investigators
- Bahaa Os Taha, Master of internal medicine, Principal investigator, Assiut UniversityZain elabdeen Ah Sayed, Doctorate of internal medicine, Study director, AssiutAlaa El Abdelmonem, Doctorate of internal medicine, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820284
- Sponsor's protocol ID
- L23457
- Status last verified
- Jun 2021
- First submitted
- 19 Jan 2019
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Helicobacter Pylori and Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03820284
- Acronym / sponsor ID
- L23457
- Conditions
- Helicobacter Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 29 Jan 2019 (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.
Introduction:
Helicobacter pylori has been linked to a variety of gastric and extra gastric diseases. Chronic infection with H. pylori causes histologically evident gastritis in all colonized individuals and is the predominant risk factor for gastric and duodenal ulcers as well as gastric adenocarcinoma. However, increasingly robust experimental and epidemiological evidence suggests that H. pylori may at the same time be beneficial to its carriers, as it efficiently prevents allergic disorders and chronic inflammatory conditions .
Inflammatory bowel disease (IBD) is characterized by chronic, nonspecific intestinal inflammation with an unexplained pathology and an alternating relapsing and remitting clinical progression. IBD is divided into two subtypes: ulcerative colitis (UC) and Crohn's disease (CD). Most studies in the IBD field attribute its etiology to the complex interactions among immune dysfunction, genetic susceptibility of the host, and environmental risk factors.
Since the twenty-first century, improving hygienic conditions and socioeconomic status have reduced the H. pylori infection rate and this trend has concurrently been accompanied by an increased IBD incidence in most countries Numerous studies have reported a lower H. pylori infection rate in patients with CD and/or UC than in non-IBD control individuals. although a small number of studies showed no significant association .Recently, emerging epidemiologic studies and animal experiments revealed an inverse correlation between H. pylori infection and IBD onset, suggesting that H. pylori colonization exerts a special protective effect on autoimmune diseases
observation Cross sectional study will be conducted at assuit university hospitals on all patients with inflammatory disease to detect the prevalence of helicobacter pylori among them .Then the examined patients will be divided in to two group receiving the same medication group A : inflammatory bowel disease patient with H.PYLORI group B: inflammatory bowel disease Patient without H.PYLORI longitudinal study will be conducted to both group to study the clinical outcomes in both group .
Detailed description
PATIENT AND METHOD :
observation Cross sectional study will be conducted at assuit university hospitals on all patients with inflammatory disease to detect the prevalence of helicobacter pylori among them .Then the examined patients will be divided in to two group receiving the same medication group A : inflammatory bowel disease patient with H.PYLORI group B: inflammatory bowel disease Patient without H.PYLORI longitudinal study will be conducted to both group to study the clinical outcomes in both group .
- Thorough medical history and full clinical examination will be taken from all patient including -Personal history focus on special habit especially smoking -documented previous history for H.pylori eradication
- Onset and duration of inflammatory bowel disease
- current medication
- presence of any extra intestinal manifestation of Inflammatory bowel disease
- presence of any complications from Inflammatory bowel disease
- Investigation : -All patients with inflammatory bowel disease will be tested for presence or absence of H.PYLORI by histological examination of endoscopically biopsied gastric mucosa -his to logical examination of colonic mucosal every 3 months -complete blood count -serum albumin -c reactive protein, erythrocyte sedimentation rate (ESR). -fecal calprotectin if possible
- assess the severity of among both group (A,B) every 3 month for 2years. ulcerative by Mayo Score/Ulcerative Colitis Disease Activity Index and Crohn's disease by Montreal classifications for Crohn's Disease . Mayo Score/Ulcerative Colitis Disease Activity Stool frequency 0 = Normal 1 = 1-2 stools/day more than normal 2 = 3-4 stools/day more than normal 3 = 4 stools/day more than normal Rectal bleeding 0 = None 1 = Visible blood with stool less than half the time 2 = Visible blood with stool half of the time or more 3 = Passing blood alone Mucosal appearance at endoscopy 0 = Normal or inactive disease 1 = Mild disease (erythema, decreased vascular pattern, mild friability) 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions) 3 = Severe disease (spontaneous bleeding, ulceration) Physician rating of disease activity 0 = Normal 1 = Mild 2 = Moderate 3 = Severe
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Group A inflammatory bowel disease with helicobacter pylori infection |
| Group B | – | –Inflammatory bowel disease without helicobacter pylori infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inflammatory bowel disease patients with or without H.pylori infection
Key inclusion criteria (1 listed)
- all inflammatory bowel disease at assiut university will be included and examined in cross sectional study for detection of presence of H.pylori in one year 2019-2020 .then the examined patients will be divided in two group A ,B according to presence or absence of H pylori . Both group will be studied in cohort study for two years
Key exclusion criteria (2 listed)
- -patients with history of administration of proton pump inhibitor or antibiotics with in eight weeks .
- patients with history of recent upper gastrointestinal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalance of H.pylori among patients with inflammatory bowel disease
Time frame: One years
Number of patient with inflammatory bowel disease with H.pylori infection
Mayo score activity index among ulcerative colitis patients with H.pylori and without H.pylori
Time frame: Two years
Stool frequency 0 = Normal 1 = 1-2 stools/day more than normal 2 = 3-4 stools/day more than normal 3 = 4 stools/day more than normal Rectal bleeding 0 = None 1 = Visible blood with stool less than half the time 2 = Visible blood with stool half of the time or more 3 = Passing blood alone Mucosal appearance at endoscopy 0 = Normal or inactive disease 1 = Mild disease (erythema, decreased vascular pattern, mild friability) 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions) 3 = Severe disease (spontaneous bleeding, ulceration) Physician rating of disease activity 0 = Normal 1 = Mild 2 = Moderate 3 = Severe
Mucosal healing among inflammatory bowel disease with H.pylori and without H.pylori
Time frame: 1years
Histological examination of the biopsied colonic mucosal every 3 months in both groups
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 30 Jun 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. This study is not recruiting at the moment.
Bahaa Os Taha, Master of internal medicine principal investigator
Assiut University
Zain elabdeen Ah Sayed, Doctorate of internal medicine study director
Assiut
Alaa El Abdelmonem, Doctorate of internal medicine study chair
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 Helicobacter Infections, 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 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 30 Jun 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?
prevalance of H.pylori among patients with inflammatory bowel disease (time frame: One years). The study lists 3 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 30 Jun 2021.