A Study of How Common Bile Acid Malabsorption is in Patients with Diarrhea Predominant Irritable Bowel Syndrome
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-000014
Sponsor Protocol Number: 15-000014
About this study
The purpose of this study is to assess how common bile acid malabsorption is in patients that have diarrhea predominant irritable bowel syndrome, by measuring blood samples for bile acids and abnormal levels of regulating hormones.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Prior diagnosis of IBS-D or functional diarrhea at Mayo Clinic will be specifically recruited and invited to participate
- Patients with prior measurements of 48h total fecal bile acids or serum C4 will NOT be excluded
- IBS symptoms positive by Rome III criteria
- Functional Diarrhea
- Loose (mushy) or watery stools without pain occurring in at least 75% of stools
- Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
- Age 18-65 years
- Men or women
- Ratio of 5 female to 1 male expected
- Lactating women are eligible
Exclusion Criteria
- Women who are currently pregnant are not eligible to participate due to changes in hepatic metabolism or cholestasis that may occur during pregnancy
- Use of drugs or agents within the past 1 week or planned use in the subsequent 10 days during the study period
- Birth control pill, estrogen replacement therapy, metformin and thyroxine replacement are permissible exceptions
- Agents that alter GI transit including opioids, narcotics, anticholinergics
- Analgesic drugs including opiates and COX 2 inhibitors
- Intake of medication that could interfere with the interpretation of the study
- Abdominal surgery (except appendectomy) specifically, prior gastric surgery, vagotomy, cholecystectomy and any small bowel resection will be excluded
- Known chronic liver disease or history of elevated AST/ALT 2.0 X ULN
- BA synthesis and possible false positive or negative fecal bile acid or serum 7alphaC4 result
- If there are no AST or ALT values in the medical record, the study physicians will determine if the tests need to be run
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Michael Camilleri, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available