Irritable Bowel SyndromeNCT04847401
the Relationship Between Helicobacter Pylori Infection and Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by Sohag University.
Trial summary
Evaluating any possible relationship between irritable bowel syndrome occurrence and Helicobacter pylori infection Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- H. pylori stool antigen
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2021to 1 Jan 2022
- How long will I take part?
- 1 Day
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: outpatient clinic patients
Who may be able to join
- All patients will be selected according to Rome IV criteria for the diagnosis of IBS, which include:
- Recurrent abdominal pain at least 1 day/week in the last 3 months, with two or more of the following criteria:
- Related to defecation
- Associated with a change in frequency of stool
- Associated with a change in form of stool. Criteria achieved for the last 3 months with symptom onset at least 6 months before diagnosis
Who cannot join
- • Rectal bleeding
- Anemia
- Weight loss
- Onset after 50 years of age
- Recent antibiotic use
- Abnormal abdominal examination (organomegaly, lump)
- Family history of colorectal cancer.
- Family history of inflammatory bowel disease, or celiac disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Relationship Between Helicobacter Pylori Infection and Irritable Bowel Syndrome
Evaluating any possible relationship between irritable bowel syndrome occurrence and Helicobacter pylori infection
- Conditions
- Irritable Bowel Syndrome
- Being tested
- H. pylori stool antigen
- Keywords
- Helicobacter Pylori, Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H. pylori stool antigenDiagnostic test
using H. pylori antigen kits in stool
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | patients with Irritable Bowel Syndrome Receives: Diagnostic Test: H. pylori stool antigen | |
| Group 2 | normal Receives: Diagnostic Test: H. pylori stool antigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of irritable bowel syndrome patients who had H.pylori infection
H.pylori stool antigen kits
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start25 May 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mohy El-Din Kamel, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847401
- Sponsor's protocol ID
- Soh-Med-21-04-03
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Helicobacter Pylori Infection and Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04847401
- Acronym / sponsor ID
- Soh-Med-21-04-03
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Helicobacter Pylori, Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 May 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 19 Apr 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.
Evaluating any possible relationship between irritable bowel syndrome occurrence and Helicobacter pylori infection
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: H. pylori stool antigenpatients with Irritable Bowel Syndrome |
| Group 2 | – | Diagnostic Test: H. pylori stool antigennormal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- outpatient clinic patients
Key inclusion criteria (5 listed)
- All patients will be selected according to Rome IV criteria for the diagnosis of IBS, which include:
- Recurrent abdominal pain at least 1 day/week in the last 3 months, with two or more of the following criteria:
- Related to defecation
- Associated with a change in frequency of stool
- Associated with a change in form of stool. Criteria achieved for the last 3 months with symptom onset at least 6 months before diagnosis
Key exclusion criteria (8 listed)
- • Rectal bleeding
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 |
|---|---|---|
| H. pylori stool antigenusing H. pylori antigen kits in stool | Diagnostic test | Group 1, Group 2 |
Primary outcome
number of irritable bowel syndrome patients who had H.pylori infection
Time frame: through study completion, an average of 1 year
H.pylori stool antigen kits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Sohag 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 5 inclusion and 8 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 19 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham Mohy Kamel, MBBCh (01274648573, reham.amin@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of irritable bowel syndrome patients who had H.pylori infection (time frame: through study completion, an average of 1 year). 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 19 Apr 2021.