The Role of Bile Acid Diarrhea in Adolescents with 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: 17-000872
Sponsor Protocol Number: 17-000872
About this study
The purpose of this study is to measure 48 hour fecal bile acids in IBS-D adolescents and compare it to HC; measure serum C4 and FGF-19 in adolescents with IBS-D and HC and compare it to 48 hour fecal bile acid loss; measure primary bile acids concentration in 48 hour stool collection in adolescents with IBS-D and compare it to HC.
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:
Adolescents with IBS-D
- Age: 8-17 years
- Gender: male or female
- IBS-D diagnosis according to ROME IV criteria using Abridged bowel symptom questionnaire (16) and validated stool diary card (attached in appendix)
- No other underlying cause to account for gastrointestinal symptoms
Healthy adolescents with no gastrointestinal symptoms
- Age: 8-17 years
- Gender: male or female
- No known gastrointestinal disease
Exclusion Criteria:
Adolescents with IBS-D
- Previous abdominal surgery
- Systemic antibiotic use within 3 months of collection
Healthy adolescents with no gastrointestinal symptoms
- Patients with previous abdominal surgeries
- Gastrointestinal symptoms suggestive of functional gastrointestinal disorders
- Systemic antibiotic use within 3 months of collection
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 Mhd Louai Manini, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available