Diarrhoea Predominant Irritable Bowel SyndromeNCT02419963
Analyzing IBS to Identify Biomarkers and Microbiome Signatures
A study testing endoscopy for tissue biopsy, Blood Sample and Stool Sample in people with Diarrhoea Predominant Irritable Bowel Syndrome and IBS, run by Mayo Clinic at 1 site in United States.
Trial summary
Microbiota from fecal samples from IBS-D patients, in combination with vitamin D supplementation added to our 3-D immunocompetent intestinal models will establish a high fidelity disease model to achieve our long-term goal to understand the relationship between gut microbiome, vitamin D levels, host gene expression… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhoea Predominant Irritable Bowel Syndrome, IBS
- What is being tested?
- endoscopy for tissue biopsy, Blood Sample and Stool Sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 12 Dec 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- IBS-D subjects:
- Patients who fulfill IBS-D criteria, without causes of active inflammation.
- active symptoms for at least 2 months
- diagnosed at least 6 months prior to enrollment
- Healthy Control:
- Healthy control patients should have no active infection or inflammation.
Who cannot join
- does not meet inclusion criteria
- will not participate in blood draw, stool sample donation, or endoscopy
- history of acute illness within 3 months of testing
- any fecal transplant history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Dimension in Modeling Irritable Bowel Syndrome (IBS) to Elucidate Novel Diagnostic Biomarkers and Microbiome Signatures
Microbiota from fecal samples from IBS-D patients, in combination with vitamin D supplementation added to our 3-D immunocompetent intestinal models will establish a high fidelity disease model to achieve our long-term goal to understand the relationship between gut microbiome, vitamin D levels, host gene expression and IBS-D symptoms that could ultimately be used as a testing platform for treatment and prevention.
Read the detailed description
The pathophysiology of IBS is not well understood. Preliminary studies support IBS-D patients with varied microbiome fingerprints, vitamin D levels, and blood serotonin levels compared to non-IBS patients. The investigators have novel 3-D immunocompetent intestinal models to establish a new model of high fidelity disease to examine the relationship of IBS-D patients gut microbiome, with supplemental vitamin D levels, and the relationship of blood serotonin and vitamin D levels. IBS-D patients and healthy controls will be asked to provide a fecal sample, a biopsy sample of colonic tissue obtained during a clinically appropriate flexible sigmoidoscopy or colonoscopy, and a blood sample. There will be 1-2 office visits. One visit will last 30 minutes, the second visit no longer than 3 hours. This study is funded by a combined MAYO-Arizona State University seed grant. The samples will be analyzed at ASU. Our long-term goal is to understand the relationship between gut microbiome, vitamin D levels, host gene expression, serotonin levels, and IBS-D symptoms that could ultimately be used as a testing platform for treatment and prevention of this highly prevalent disorder.
- Being tested
- endoscopy for tissue biopsy, Blood Sample, Stool Sample
- Keywords
- microbiome, biomarkers, Vitamin D, Serotonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopy for tissue biopsyProcedure or surgery
Also called Sigmoidoscopy
endoscopy to obtain tissue biopsy for analysis of biomarker status
Blood SampleOther
Blood draw to evaluate serotonin and Vit D level.
Stool SampleOther
Stool sample to evaluate microbiome fingerprint.
| Study group | Role | What they receive |
|---|---|---|
| IBS-D patients | Other | Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples. Receives: Procedure: endoscopy for tissue biopsy; Other: Blood Sample; Other: Stool Sample |
| Healthy Controls | Other | Subjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples. Receives: Procedure: endoscopy for tissue biopsy; Other: Blood Sample; Other: Stool Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotonin level
2 blood vials will be drawn during the flexible sigmoidoscopy or colonoscopy procedure, and serotonin levels will be drawn from one of these blood samples.
Measured: Study Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startMay 2015
- Primary completion12 Dec 2016
- Study completion12 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhoea Predominant 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Foxx-Orenstein, Mayo Clinic
- Investigators
- Amy Foxx-Orenstein, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419963
- Sponsor's protocol ID
- 14-008799
- Status last verified
- Jul 2017
- First submitted
- 30 Jan 2015
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Dimension in Modeling Irritable Bowel Syndrome (IBS) to Elucidate Novel Diagnostic Biomarkers and Microbiome Signatures
- ClinicalTrials.gov ID
- NCT02419963
- Acronym / sponsor ID
- 14-008799
- Keywords
- microbiome, biomarkers, Vitamin D, Serotonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 12 Dec 2016 (actual)
- First posted
- 17 Apr 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.
Microbiota from fecal samples from IBS-D patients, in combination with vitamin D supplementation added to our 3-D immunocompetent intestinal models will establish a high fidelity disease model to achieve our long-term goal to understand the relationship between gut microbiome, vitamin D levels, host gene expression and IBS-D symptoms that could ultimately be used as a testing platform for treatment and prevention.
Detailed description
The pathophysiology of IBS is not well understood. Preliminary studies support IBS-D patients with varied microbiome fingerprints, vitamin D levels, and blood serotonin levels compared to non-IBS patients. The investigators have novel 3-D immunocompetent intestinal models to establish a new model of high fidelity disease to examine the relationship of IBS-D patients gut microbiome, with supplemental vitamin D levels, and the relationship of blood serotonin and vitamin D levels. IBS-D patients and healthy controls will be asked to provide a fecal sample, a biopsy sample of colonic tissue obtained during a clinically appropriate flexible sigmoidoscopy or colonoscopy, and a blood sample. There will be 1-2 office visits. One visit will last 30 minutes, the second visit no longer than 3 hours. This study is funded by a combined MAYO-Arizona State University seed grant. The samples will be analyzed at ASU. Our long-term goal is to understand the relationship between gut microbiome, vitamin D levels, host gene expression, serotonin levels, and IBS-D symptoms that could ultimately be used as a testing platform for treatment and prevention of this highly prevalent disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS-D patients | Other | Procedure: endoscopy for tissue biopsy, Other: Blood Sample, Other: Stool SampleSubjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples. |
| Healthy Controls | Other | Procedure: endoscopy for tissue biopsy, Other: Blood Sample, Other: Stool SampleSubjects on this arm will have an endoscopy for tissue biopsy, and provide blood samples and stool samples. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who fulfill IBS-D criteria, without causes of active inflammation.
- active symptoms for at least 2 months
- diagnosed at least 6 months prior to enrollment
- Healthy control patients should have no active infection or inflammation.
Key exclusion criteria (4 listed)
- does not meet inclusion criteria
- will not participate in blood draw, stool sample donation, or endoscopy
- history of acute illness within 3 months of testing
- any fecal transplant history
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 |
|---|---|---|
| endoscopy for tissue biopsyAlso: Sigmoidoscopyendoscopy to obtain tissue biopsy for analysis of biomarker status | Procedure or surgery | Healthy Controls, IBS-D patients |
| Blood SampleBlood draw to evaluate serotonin and Vit D level. | Other | Healthy Controls, IBS-D patients |
| Stool SampleStool sample to evaluate microbiome fingerprint. | Other | Healthy Controls, IBS-D patients |
Primary outcome
Serotonin level
Time frame: Study Day 2
2 blood vials will be drawn during the flexible sigmoidoscopy or colonoscopy procedure, and serotonin levels will be drawn from one of these blood samples.
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 7 Jul 2017.
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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.
Amy Foxx-Orenstein, DO principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopy for tissue biopsy, Blood Sample and Stool Sample in people with Diarrhoea Predominant Irritable Bowel Syndrome and IBS, run by Mayo Clinic 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 6 inclusion and 4 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 7 Jul 2017. 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 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?
Serotonin level (time frame: Study Day 2). 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 7 Jul 2017.