Recruiting

Mannitol Solution

Sponsor:

Mayo Clinic

Code:

NCT07817706

Conditions

Disorders of Gut Brain Interaction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Mannitol Solution 76 mOsm/L

Mannitol Solution 189 mOsm/L

Mannitol Solution 325 mOsm/L

Scintigraphy

Study Details

Brief 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.

Conditions

Disorders of Gut Brain Interaction

Study ID

NCT07817706

Start date

Aug 24, 2026

Status verified date

Sep, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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).

Interventions

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.

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.

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.

Scintigraphy

Scintigraphy will be used to track gastric emptying, small bowel transit, and colonic filling of the radiolabeled mannitol solution during each testing visit.

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. ]
  • Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 189 mOsm/L Mannitol Solution Ingestion [ Time Frame: At baseline and at 15-minute intervals beginning 30 minutes after ingestion through 180 minutes post-ingestion. ]
  • Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 325 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 and Locations

Central contacts

Taylor Hines

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

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Taylor Hines

507-538-9959

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-14.