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

September 8, 2026 updated by: Xiao Jing (Iris) Wang, Mayo Clinic
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Taylor Hines
          • Phone Number: 507-538-9959

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 will be assessed using a 7-point Likert symptom scale after ingestion of radiolabeled mannitol solution. Symptoms assessed include abdominal pain or discomfort, nausea, bloating, distension, borborygmi, diarrhea, urgency, and related gastrointestinal symptoms. The peak symptom score observed during the small bowel phase will be identified. The small bowel phase is defined as the period during which scintigraphy confirms radiolabeled solution in the small bowel and before more than 25% of tracer has reached the ascending colon. Scores range from 1 to 7, with higher scores indicating greater symptom severity.
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 will be assessed using a 7-point Likert symptom scale after ingestion of radiolabeled mannitol solution. Symptoms assessed include abdominal pain or discomfort, nausea, bloating, distension, borborygmi, diarrhea, urgency, and related gastrointestinal symptoms. The peak symptom score observed during the small bowel phase will be identified. The small bowel phase is defined as the period during which scintigraphy confirms radiolabeled solution in the small bowel and before more than 25% of tracer has reached the ascending colon. Scores range from 1 to 7, with higher scores indicating greater symptom severity.
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.
Peak gastrointestinal symptom severity will be assessed using a 7-point Likert symptom scale after ingestion of radiolabeled mannitol solution. Symptoms assessed include abdominal pain or discomfort, nausea, bloating, distension, borborygmi, diarrhea, urgency, and related gastrointestinal symptoms. The peak symptom score observed during the small bowel phase will be identified. The small bowel phase is defined as the period during which scintigraphy confirms radiolabeled solution in the small bowel and before more than 25% of tracer has reached the ascending colon. Scores range from 1 to 7, with higher scores indicating greater symptom severity.
At baseline and at 15-minute intervals beginning 30 minutes after ingestion through 180 minutes post-ingestion.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak Abdominal Pain Intensity Following 76 mOsm/L Mannitol Solution
Time Frame: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak abdominal pain intensity will be assessed after ingestion of 500 mL radiolabeled 76 mOsm/L mannitol solution using the Kohn Reactivity Scale. The peak pain intensity score observed during the small bowel phase will be identified. The small bowel phase is defined as the period during which scintigraphy confirms radiolabeled solution in the small bowel and before more than 25% of tracer has reached the ascending colon. Higher scores indicate greater pain intensity.
Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak Abdominal Pain Intensity Following 189 mOsm/L Mannitol Solution
Time Frame: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak abdominal pain intensity will be assessed after ingestion of 500 mL radiolabeled 189 mOsm/L mannitol solution using the Kohn Reactivity Scale. The peak pain intensity score observed during the small bowel phase will be identified. The small bowel phase is defined as the period during which scintigraphy confirms radiolabeled solution in the small bowel and before more than 25% of tracer has reached the ascending colon. Higher scores indicate greater pain intensity.
Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak Abdominal Pain Intensity Following 325 mOsm/L Mannitol Solution
Time Frame: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak abdominal pain intensity will be assessed after ingestion of 500 mL radiolabeled 325 mOsm/L mannitol solution using the Kohn Reactivity Scale. The peak pain intensity score observed during the small bowel phase will be identified. The small bowel phase is defined as the period during which scintigraphy confirms radiolabeled solution in the small bowel and before more than 25% of tracer has reached the ascending colon. Higher scores indicate greater pain intensity.
Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak Abdominal Pain Unpleasantness Following 76 mOsm/L Mannitol Solution
Time Frame: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak abdominal pain unpleasantness will be assessed after ingestion of 500 mL radiolabeled 76 mOsm/L mannitol solution using the Kohn Reactivity Scale. The peak pain unpleasantness score observed during the small bowel phase will be identified. The small bowel phase is defined as the period during which scintigraphy confirms radiolabeled solution in the small bowel and before more than 25% of tracer has reached the ascending colon. Higher scores indicate greater pain unpleasantness.
Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak Abdominal Pain Unpleasantness Following 189 mOsm/L Mannitol Solution
Time Frame: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak abdominal pain unpleasantness will be assessed after ingestion of 500 mL radiolabeled 189 mOsm/L mannitol solution using the Kohn Reactivity Scale. The peak pain unpleasantness score observed during the small bowel phase will be identified. The small bowel phase is defined as the period during which scintigraphy confirms radiolabeled solution in the small bowel and before more than 25% of tracer has reached the ascending colon. Higher scores indicate greater pain unpleasantness.
Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak Abdominal Pain Unpleasantness Following 325 mOsm/L Mannitol Solution
Time Frame: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak abdominal pain unpleasantness will be assessed after ingestion of 500 mL radiolabeled 325 mOsm/L mannitol solution using the Kohn Reactivity Scale. The peak pain unpleasantness score observed during the small bowel phase will be identified. The small bowel phase is defined as the period during which scintigraphy confirms radiolabeled solution in the small bowel and before more than 25% of tracer has reached the ascending colon. Higher scores indicate greater pain unpleasantness.
Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Change in Gastrointestinal Symptom Severity Following 76 mOsm/L Mannitol Solution
Time Frame: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Gastrointestinal symptom severity will be assessed after ingestion of 500 mL radiolabeled 76 mOsm/L mannitol solution using a modified Gastric Symptom Severity Scale. Symptoms assessed include abdominal pain or discomfort, nausea, bloating, distension, borborygmi, diarrhea, loose stools, urgency, and related gastrointestinal symptoms. Scores range from 1 to 7, with higher scores indicating greater symptom severity.
Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Change in Gastrointestinal Symptom Severity Following 189 mOsm/L Mannitol Solution
Time Frame: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Gastrointestinal symptom severity will be assessed after ingestion of 500 mL radiolabeled 189 mOsm/L mannitol solution using a modified Gastric Symptom Severity Scale. Symptoms assessed include abdominal pain or discomfort, nausea, bloating, distension, borborygmi, diarrhea, loose stools, urgency, and related gastrointestinal symptoms. Scores range from 1 to 7, with higher scores indicating greater symptom severity.
Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Change in Gastrointestinal Symptom Severity Following 325 mOsm/L Mannitol Solution
Time Frame: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Gastrointestinal symptom severity will be assessed after ingestion of 500 mL radiolabeled 325 mOsm/L mannitol solution using a modified Gastric Symptom Severity Scale. Symptoms assessed include abdominal pain or discomfort, nausea, bloating, distension, borborygmi, diarrhea, loose stools, urgency, and related gastrointestinal symptoms. Scores range from 1 to 7, with higher scores indicating greater symptom severity.
Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiao Jing Wang, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-013906

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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