Irritable Bowel SyndromeGPSSNCT02358564
Gut Permeability, Sensitivity and Symptomatology
A study testing Gastrointestinal Permeability Test, Upper Endoscopy and Rectal Barostat and Infusion of Fats in people with Irritable Bowel Syndrome and Visceral Hypersensitivity, run by Mayo Clinic at 2 sites in United States.
Trial summary
To better understand the relationship between gut barrier function and the symptomatology and pathophysiology of irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Visceral Hypersensitivity
- What is being tested?
- Gastrointestinal Permeability Test, Upper Endoscopy and Rectal Barostat and Infusion of Fats
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to 11 Mar 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years
- No abdominal surgery (except appendectomy, cholecystectomy, hernia repair, hysterectomy, and C-section).
- Written informed consent
Who cannot join
- Females who are pregnant or breastfeeding
- Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
- Use of oral corticosteroids within the previous 6 weeks
- Ingestion of artificial sweeteners such as Splenda (sucralose), Nutrasweet (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g. foods to be avoided are sugarless gyms or mints and diet soda.
- Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before the study begins.
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- Proton pump inhibitors.
- Antibiotics for the preceding 60 days before the start of the study.
- (vii) Alcohol intake beyond the recommended safe limit (<21 unites per week)
- Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
- Known allergy to fluorescein
- Inflammatory bowel diseases, celiac disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Gut Permeability, Sensitivity and Symptomatology: Is There a Link and Explanation for Exacerbation of Symptoms Post Meals
To better understand the relationship between gut barrier function and the symptomatology and pathophysiology of irritable bowel syndrome (IBS).
- Being tested
- Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats
- Keywords
- IBS, Irritable Bowel Syndrome, Visceral Hypersensitivity, Permeability, Small Bowel, Lactulose, Mannitol
- 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.
Gastrointestinal Permeability TestProcedure or surgery
This test will involve ingesting a solution followed by urinalysis
Upper EndoscopyProcedure or surgery
Rectal Barostat and Infusion of FatsProcedure or surgery
Feeding tube will be placed, as well as a small balloon in the rectum.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Active comparator | Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats. Receives: Procedure: Gastrointestinal Permeability Test; Procedure: Upper Endoscopy; Procedure: Rectal Barostat and Infusion of Fats |
| Irritable Bowel Syndrome Patients | Experimental | Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats. Receives: Procedure: Gastrointestinal Permeability Test; Procedure: Upper Endoscopy; Procedure: Rectal Barostat and Infusion of Fats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent of complete epithelial cell loss
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion11 Mar 2021
- Study completion11 Mar 2021
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 Mayo ClinicThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Erlangen-Nürnberg, Heidelberg University, University of Leeds
- Responsible party
- Principal investigator, Madhusudan (Madhu) Grover, MBBS, Mayo Clinic
- Investigators
- Madhusudan Grover, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358564
- Sponsor's protocol ID
- 14-000837
- Acronym
- GPSS
- Status last verified
- Sep 2021
- First submitted
- 30 Jan 2015
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Permeability, Sensitivity and Symptomatology: Is There a Link and Explanation for Exacerbation of Symptoms Post Meals
- ClinicalTrials.gov ID
- NCT02358564
- Acronym / sponsor ID
- GPSS / 14-000837
- Keywords
- IBS, Irritable Bowel Syndrome, Visceral Hypersensitivity, Permeability, Small Bowel, Lactulose, Mannitol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Erlangen-Nürnberg, Heidelberg University, University of Leeds
- Study start
- Feb 2015
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 9 Feb 2015 (estimated)
- 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.
To better understand the relationship between gut barrier function and the symptomatology and pathophysiology of irritable bowel syndrome (IBS).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Active comparator | Procedure: Gastrointestinal Permeability Test, Procedure: Upper Endoscopy, Procedure: Rectal Barostat and Infusion of FatsParticipants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats. |
| Irritable Bowel Syndrome Patients | Experimental | Procedure: Gastrointestinal Permeability Test, Procedure: Upper Endoscopy, Procedure: Rectal Barostat and Infusion of FatsParticipants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 70 years
- No abdominal surgery (except appendectomy, cholecystectomy, hernia repair, hysterectomy, and C-section).
- Written informed consent
Key exclusion criteria (12 listed)
- Females who are pregnant or breastfeeding
- Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
- Use of oral corticosteroids within the previous 6 weeks
- Ingestion of artificial sweeteners such as Splenda (sucralose), Nutrasweet (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g. foods to be avoided are sugarless gyms or mints and diet soda.
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 |
|---|---|---|
| Gastrointestinal Permeability TestThis test will involve ingesting a solution followed by urinalysis | Procedure or surgery | Healthy Volunteers, Irritable Bowel Syndrome Patients |
| Upper Endoscopy | Procedure or surgery | Healthy Volunteers, Irritable Bowel Syndrome Patients |
| Rectal Barostat and Infusion of FatsFeeding tube will be placed, as well as a small balloon in the rectum. | Procedure or surgery | Healthy Volunteers, Irritable Bowel Syndrome Patients |
Primary outcome
Mean Percent of complete epithelial cell loss
Time frame: 72 hours
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 5 Sep 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Madhusudan Grover, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastrointestinal Permeability Test, Upper Endoscopy and Rectal Barostat and Infusion of Fats in people with Irritable Bowel Syndrome and Visceral Hypersensitivity, run by Mayo Clinic at 2 sites in United States.
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 3 inclusion and 12 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Mean Percent of complete epithelial cell loss (time frame: 72 hours). 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 5 Sep 2021.