A Study to Evaluate the Development and Validation of Disaccharidase Determination from Small Bowel Biopsy Specimens.
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: 18-004602
Sponsor Protocol Number: 18-004602
About this study
The purpose of this study is to prospectively collect a microscopic biopsy from individuals who have a clinical suspicion of a possible gastrointestinal disaccharidase deficiency, and to develop and validate clinical enzymatic assays for intestinal disaccharidase lactase, palatinase, sucrase, maltase, or glucoamylase (Disaccharidase Enzyme Panel) in order to detect deficiencies in these enzymes, thereby benefiting the diagnosis of gastrointestinal disorders at Mayo Clinic.
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:
- Patients less than age 18 years old.
- Patients with known or suspected gastrointestinal disorder associated with malfunction of intestinal disaccharidases.
Exclusion Criteria:
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 Devin Oglesbee, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available