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

Conditions

• Disorders of Gut Brain Interaction

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Mannitol Solution 76 mOsm/L — DRUG
  Participants will ingest 500 mL of mannitol solution at 76 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
• Mannitol Solution 189 mOsm/L — DRUG
  Participants will ingest 500 mL of mannitol solution at 189 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
• Mannitol Solution 325 mOsm/L — DRUG
  Participants will ingest 500 mL of mannitol solution at 325 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
• Scintigraphy — DIAGNOSTIC_TEST
  Scintigraphy will be used to track gastric emptying, small bowel transit, and colonic filling of the radiolabeled mannitol solution during each testing visit.

Study Details

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.

Key Dates

First listed

Sep 14, 2026

Start date

Aug 24, 2026

Status verified

Sep 2026

Primary completion

Jun 30, 2027

Completion

Dec 30, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• 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).

Primary Outcome Measure

Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 76 mOsm/L Mannitol Solution Ingestion [ Time Frame: At baseline and at 15-minute intervals beginning 30 minutes after ingestion through 180 minutes post-ingestion. ]

Central Contacts

• Taylor Hines
  507-538-9959
  [email protected]

Locations (1)

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