GERDNCT04759378
Comorbid Esophageal Disorders in IBS Patients
A study testing Upper endoscopy, esophageal manometry, 24-hour pH monitoring in people with GERD and Non-erosive Reflux Disease, run by Assiut University.
Trial summary
assess the incidence of the entire spectrum of esophageal disorders and possible theories for overlap in IBS patients using different diagnostic modalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD, Non-erosive Reflux Disease, Functional Esophageal Disorders
- What is being tested?
- Upper endoscopy, esophageal manometry, 24-hour pH monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2021to 1 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of IBS (according to the Rome criteria of the III revision).
- Upper GIT symptoms in the form of heartburn (sometimes belching), a lump in the throat, and non-cardiac chest pain.
Who cannot join
- History of thoracic, esophageal, or gastric surgery.
- Presence of duodenal or gastric ulcer on upper endoscopy.
- Presence of duodenal or gastric cancer on upper endoscopy.
- Conditions that prevent the installation of a nasogastric tube (nasopharyngeal formation, severe lumen-facial trauma).
- mental disorders state and disability.
- Pregnancy and breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comorbid Disorders of the Esophagus in Patients With Irritable Bowel Disease
assess the incidence of the entire spectrum of esophageal disorders and possible theories for overlap in IBS patients using different diagnostic modalities.
Read the detailed description
In the practice of a gastroenterologist, irritable bowel syndrome (IBS) is the most frequent functional disorder. Its prevalence in the population is 9.8%-12.8%. Its frequency in women is more than men. In some studies, it has been shown that a patient may have an overlap of symptoms of different functional diseases of the gastrointestinal tract. Different researchers have ambiguously assessed the frequency of occurrence of esophageal disorders in patients with IBS. So, based on the publications of different authors, they are found in 15-80% of cases. In a study by N. de Bortoli et al. (2016) noted the association of IBS with functional heartburn in 77% of cases, and with GERD and hypersensitive esophagus (called heartburn associated with reflux) - in 33% of cases.
Traditionally, diagnostics of a combination of functional disorders of the esophagus and intestines were based on data X-ray and endoscopic methods. However modern research has shown the importance of using in this group of patients with daily combined pH impedance measurement. Thus, many authors have noted the undoubted advantages of this method in the diagnosis of esophageal disorders. Unfortunately, works devoted to this topic, extremely few in number, and the information obtained in them is quite contradictory, which indicates the need to continue research in this direction.
- Conditions
- GERD, Non-erosive Reflux Disease, Functional Esophageal Disorders, Irritable Bowel Syndrome
- Being tested
- Upper endoscopy, esophageal manometry, 24-hour pH monitoring
- Medical subject headings
- Gastroesophageal Reflux, Non-Erosive Reflux Disease, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper endoscopy, esophageal manometry, 24-hour pH monitoringDiagnostic test
upper endoscopy determines if there are structural abnormalities in upper Git. esophageal manometry determines if there are motility disorders. 24-hour pH monitoring determines if acid reflux is present or not, and specifies its rate and duration.
| Study group | Role | What they receive |
|---|---|---|
| IBS patients who have upper GIT symptoms | Experimental | Not described Receives: Diagnostic Test: Upper endoscopy, esophageal manometry, 24-hour pH monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of GERD in IBS patients who have upper GIT symptoms
use the result of the comprehensive examination, upper endoscopy, esophageal manometry, and 24h pH monitoring to reveal that comorbid disorders of the esophagus in patients with IBS.
Measured: baseline
Incidence of Functional esophageal disorders in IBS patient who have upper GIT symptoms.
use the result of the comprehensive examination, including upper endoscopy, esophageal manometry, and 24h pH monitoring to reveal that comorbid disorders of the esophagus in patients with IBS.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start25 Feb 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bishoy Shehata, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759378
- Sponsor's protocol ID
- esophageal disorders and IBS
- Status last verified
- Feb 2021
- First submitted
- 12 Jan 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comorbid Disorders of the Esophagus in Patients With Irritable Bowel Disease
- ClinicalTrials.gov ID
- NCT04759378
- Acronym / sponsor ID
- esophageal disorders and IBS
- Conditions
- GERD, Non-erosive Reflux Disease, Functional Esophageal Disorders, Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Feb 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 18 Feb 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.
assess the incidence of the entire spectrum of esophageal disorders and possible theories for overlap in IBS patients using different diagnostic modalities.
Detailed description
In the practice of a gastroenterologist, irritable bowel syndrome (IBS) is the most frequent functional disorder. Its prevalence in the population is 9.8%-12.8%. Its frequency in women is more than men. In some studies, it has been shown that a patient may have an overlap of symptoms of different functional diseases of the gastrointestinal tract. Different researchers have ambiguously assessed the frequency of occurrence of esophageal disorders in patients with IBS. So, based on the publications of different authors, they are found in 15-80% of cases. In a study by N. de Bortoli et al. (2016) noted the association of IBS with functional heartburn in 77% of cases, and with GERD and hypersensitive esophagus (called heartburn associated with reflux) - in 33% of cases.
Traditionally, diagnostics of a combination of functional disorders of the esophagus and intestines were based on data X-ray and endoscopic methods. However modern research has shown the importance of using in this group of patients with daily combined pH impedance measurement. Thus, many authors have noted the undoubted advantages of this method in the diagnosis of esophageal disorders. Unfortunately, works devoted to this topic, extremely few in number, and the information obtained in them is quite contradictory, which indicates the need to continue research in this direction.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBS patients who have upper GIT symptoms | Experimental | Diagnostic Test: Upper endoscopy, esophageal manometry, 24-hour pH monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Established diagnosis of IBS (according to the Rome criteria of the III revision).
- Upper GIT symptoms in the form of heartburn (sometimes belching), a lump in the throat, and non-cardiac chest pain.
Key exclusion criteria (6 listed)
- History of thoracic, esophageal, or gastric surgery.
- Presence of duodenal or gastric ulcer on upper endoscopy.
- Presence of duodenal or gastric cancer on upper endoscopy.
- Conditions that prevent the installation of a nasogastric tube (nasopharyngeal formation, severe lumen-facial trauma).
- mental disorders state and disability.
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 |
|---|---|---|
| Upper endoscopy, esophageal manometry, 24-hour pH monitoringupper endoscopy determines if there are structural abnormalities in upper Git. esophageal manometry determines if there are motility disorders. 24-hour pH monitoring determines if acid reflux is present or not, and specifies its rate and duration. | Diagnostic test | IBS patients who have upper GIT symptoms |
Primary outcome
Incidence of GERD in IBS patients who have upper GIT symptoms
Time frame: baseline
use the result of the comprehensive examination, upper endoscopy, esophageal manometry, and 24h pH monitoring to reveal that comorbid disorders of the esophagus in patients with IBS.
Incidence of Functional esophageal disorders in IBS patient who have upper GIT symptoms.
Time frame: baseline
use the result of the comprehensive examination, including upper endoscopy, esophageal manometry, and 24h pH monitoring to reveal that comorbid disorders of the esophagus in patients with IBS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 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.
Questions about this trial
What is this clinical trial studying?
A study testing Upper endoscopy, esophageal manometry, 24-hour pH monitoring in people with GERD and Non-erosive Reflux Disease, run by Assiut 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 2 inclusion and 6 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 18 Feb 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 bishoy s shehata, doctor (+201271724586, bishoy.shehata77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of GERD in IBS patients who have upper GIT symptoms (time frame: baseline). The study lists 2 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 18 Feb 2021.