Development of a Noninvasive Metric to Measure Small Bowel Sensation - The Small Intestine Stress Test

Purpose

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.

Condition

  • Disorders of Gut Brain Interaction

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Healthy Volunteers Receiving Mannitol Solutions 		Healthy adult volunteers will receive all three mannitol solution osmolarities-76 milliosmol (mOsm/L), 189 mOsm/L, and 325 mOsm/L-on three separate testing occasions spaced at least 5 days apart. Each solution will be administered orally as 500 mL radiolabeled with Pentetate Indium Disodium In-111 (111Indium-DTPA).
  • Drug: Mannitol Solution 76 mOsm/L
    Participants will ingest 500 mL of mannitol solution at 76 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
  • Drug: Mannitol Solution 189 mOsm/L
    Participants will ingest 500 mL of mannitol solution at 189 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
  • Drug: Mannitol Solution 325 mOsm/L
    Participants will ingest 500 mL of mannitol solution at 325 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
  • Diagnostic Test: Scintigraphy
    Scintigraphy will be used to track gastric emptying, small bowel transit, and colonic filling of the radiolabeled mannitol solution during each testing visit.

Recruiting Locations

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Taylor Hines
507-538-9959

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Taylor Hines
507-538-9959
hines.taylor@mayo.edu