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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

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Conditions

Disorders of Gut Brain Interaction

Locations

Mayo Clinic

Rochester, Minnesota 55905

United States