Diarrhoea Predominant Irritable Bowel Syndrome, IBS
Conditions
Keywords
microbiome, biomarkers, Vitamin D, Serotonin
Brief 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 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.
Interventions
PROCEDUREendoscopy for tissue biopsy
endoscopy to obtain tissue biopsy for analysis of biomarker status
OTHERBlood Sample
Blood draw to evaluate serotonin and Vit D level.
OTHERStool Sample
Stool sample to evaluate microbiome fingerprint.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serotonin level | 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. |
Countries
United States
Outcome results
None listed