Irritable Bowel SyndromeNCT03529318
Mucosal Innate Immune Activation in Chronic Intestinal Disorders
An observational study of Irritable Bowel Syndrome and Inflammatory Bowel Diseases, run by University of Arkansas at 1 site in United States.
Trial summary
Crohn's disease and ulcerative colitis are types of chronic intestinal disorder called inflammatory bowel diseases (IBD) that can affect the small and large bowel causing symptoms of abdominal pain, diarrhea, blood in the stool, and weight loss. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases
- What is being tested?
- Biopsies from endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 18 Oct 2019
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject population includes patients with known Crohn's disease, ulcerative colitis and indeterminant colitis. Patients will be recruited after they check in to the endoscopy unit, and before their endoscopic procedure, prior to any pre-procedure sedation medications having been given. All participants are undergoing endoscopy with biopsy for surveillance, screening, , diagnosis , or assessment of treatment. If no biopsy specimens are taken from subjects for diagnosis, no biopsy samples are taken for research purposes. The subject enrollment goal is 60 separate subjects with Crohn's disease, ulcerative colitis and indeterminant colitis or Irritable bowel syndrome. The subjects' participation will be limited to in the endoscopy suite.
Who may be able to join
- Men and women, 18-years old and older
- Presenting at the University of Arkansas for Medical Sciences (UAMS) Endoscopy center to undergo endoscopy with biopsy for surveillance, screening or diagnosis.
Who cannot join
- Subjects classified in an anesthesia risk group , American Society of Anesthesiologists Class (ASA) ≥ 4,
- history of bleeding diathesis or coagulopathy
- stroke or transient neurological attack within the last 6 months
- pregnancy
- currently on blood thinners (excepting aspirin)
- subject is unable to consent themselves
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Crohn's disease and ulcerative colitis are types of chronic intestinal disorder called inflammatory bowel diseases (IBD) that can affect the small and large bowel causing symptoms of abdominal pain, diarrhea, blood in the stool, and weight loss. Irritable bowel syndrome (IBS) is a milder form of IBD, with symptoms of abdominal pain, bloating, diarrhea or constipation, and blood in the stool. It is not known what causes diseases such as IBD and IBS. This study will look at the events in the gut that leads to leaky gut and inflammation in patients with IBD and IBS. The study will also see if medications such as rifaximin and mesalamine may reduce the amount of leaky gut.
- Being tested
- Biopsies from endoscopy
- Medical subject headings
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsies from endoscopyProcedure or surgery
- Patients scheduled for endoscopy (EGD or colonoscopy) for IBD will be consented to allow physicians who are performing endoscopies to take additional biopsies and blood samples for "research purposes".
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of specimens showing elevated levels of mucosal innate immune activation
Determining the level of mucosal innate immune activation by staining, organoid culture, Western blot analysis, and cytokine expression on biopsy samples in IBD and IBS patient samples.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Sep 2018
- Primary completion18 Oct 2019
- Study completion18 Oct 2019 (estimated)
Why it stopped: Lack of funding
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 University of ArkansasThe 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Tharian, MD, Principal investigator, University of ArkansasJulia Liu, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529318
- Sponsor's protocol ID
- 217718
- Status last verified
- Oct 2019
- First submitted
- 7 May 2018
- Last updated
- 22 Oct 2019
- 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 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucosal Innate Immune Activation in Chronic Intestinal Disorders
- ClinicalTrials.gov ID
- NCT03529318
- Acronym / sponsor ID
- 217718
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (estimated)
- First posted
- 18 May 2018 (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.
Crohn's disease and ulcerative colitis are types of chronic intestinal disorder called inflammatory bowel diseases (IBD) that can affect the small and large bowel causing symptoms of abdominal pain, diarrhea, blood in the stool, and weight loss. Irritable bowel syndrome (IBS) is a milder form of IBD, with symptoms of abdominal pain, bloating, diarrhea or constipation, and blood in the stool. It is not known what causes diseases such as IBD and IBS. This study will look at the events in the gut that leads to leaky gut and inflammation in patients with IBD and IBS. The study will also see if medications such as rifaximin and mesalamine may reduce the amount of leaky gut.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population includes patients with known Crohn's disease, ulcerative colitis and indeterminant colitis. Patients will be recruited after they check in to the endoscopy unit, and before their endoscopic procedure, prior to any pre-procedure sedation medications having been given. All participants are undergoing endoscopy with biopsy for surveillance, screening, , diagnosis , or assessment of treatment. If no biopsy specimens are taken from subjects for diagnosis, no biopsy samples are taken for research purposes. The subject enrollment goal is 60 separate subjects with Crohn's disease, ulcerative colitis and indeterminant colitis or Irritable bowel syndrome. The subjects' participation will be limited to in the endoscopy suite.
Key inclusion criteria (2 listed)
- Men and women, 18-years old and older
- Presenting at the University of Arkansas for Medical Sciences (UAMS) Endoscopy center to undergo endoscopy with biopsy for surveillance, screening or diagnosis.
Key exclusion criteria (6 listed)
- Subjects classified in an anesthesia risk group , American Society of Anesthesiologists Class (ASA) ≥ 4,
- history of bleeding diathesis or coagulopathy
- stroke or transient neurological attack within the last 6 months
- pregnancy
- currently on blood thinners (excepting aspirin)
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 |
|---|---|---|
| Biopsies from endoscopy1) Patients scheduled for endoscopy (EGD or colonoscopy) for IBD will be consented to allow physicians who are performing endoscopies to take additional biopsies and blood samples for "research purposes". | Procedure or surgery | – |
Primary outcome
The number of specimens showing elevated levels of mucosal innate immune activation
Time frame: Up to 2 years
Determining the level of mucosal innate immune activation by staining, organoid culture, Western blot analysis, and cytokine expression on biopsy samples in IBD and IBS patient samples.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- 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.
Benjamin Tharian, MD principal investigator
University of Arkansas
Julia Liu, MD principal investigator
University of Arkansas
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 Irritable Bowel Syndrome and Inflammatory Bowel Diseases, run by University of Arkansas at 1 site 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 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: withdrawn, as of the sponsor's last update on 22 Oct 2019. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
The number of specimens showing elevated levels of mucosal innate immune activation (time frame: Up to 2 years). 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 22 Oct 2019.