NCT07817706NARecruitingAccepts Healthy Volunteers
Development of a Noninvasive Metric to Measure Small Bowel Sensation - The Small Intestine Stress Test
Mayo Clinic
Start Date
9/1/2026
Completion Date
12/30/2027
Summary
The purpose of this research is to identify the concentration of mannitol solution (a type of sugar alcohol) that will generate a range of symptoms in individuals without Disorders of Gut Brain Interaction (DGBI) to establish the normative range of responses to small bowel (SB) distension.
Eligibility Criteria
Age Range: 18 years to 75 years
Inclusion Criteria:
* No current gastrointestinal symptoms
* No prior history of GI disorders, in particular DGBIs
* Ability to provide informed consent
* Ability to participate in study procedures
* Absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results
* For females, must not be pregnant or lactating due to radiation exposure.
* Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control are permissible.
Exclusion Criteria
* Subjects on any medications that impact transit or integrity of small bowel mucosal barrier (e.g. chronic NSAIDS) of the GI tract will be excluded.
* Patients with prior bowel surgery (not including appendectomy and cholecystectomy)
* Patients who may have altered sensation (central sensitization or conditions that may induce bowel hyperalgesia) based on PI review of medical history (ie, fibromyalgia, endometriosis, chronic pelvic pain)
Interventions
DRUG
Mannitol Solution 76 mOsm/L
DRUG
Mannitol Solution 189 mOsm/L
DRUG
Mannitol Solution 325 mOsm/L
DIAGNOSTIC_TEST
Scintigraphy
Conditions
Disorders of Gut Brain Interaction
Locations
Mayo Clinic
Rochester, Minnesota 55905
United States