Disorders of Gut Brain InteractionNCT07817706
Development of a Noninvasive Metric to Measure Small Bowel Sensation - The Small Intestine Stress Test
A study testing Mannitol Solution 76 mOsm/L, Mannitol Solution 189 mOsm/L and Mannitol Solution 325 mOsm/L in people with Disorders of Gut Brain Interaction, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorders of Gut Brain Interaction
- What is being tested?
- Mannitol Solution 76 mOsm/L, Mannitol Solution 189 mOsm/L and Mannitol Solution 325 mOsm/L
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Taylor Hines, 507-538-9959
About this study
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
- Being tested
- Mannitol Solution 76 mOsm/L, Mannitol Solution 189 mOsm/L, Mannitol Solution 325 mOsm/L, Scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mannitol Solution 76 mOsm/LDrug
Participants will ingest 500 mL of mannitol solution at 76 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
Mannitol Solution 189 mOsm/LDrug
Participants will ingest 500 mL of mannitol solution at 189 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
Mannitol Solution 325 mOsm/LDrug
Participants will ingest 500 mL of mannitol solution at 325 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
ScintigraphyDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Healthy Volunteers Receiving Mannitol Solutions | Experimental | 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). Receives: Drug: Mannitol Solution 76 mOsm/L; Drug: Mannitol Solution 189 mOsm/L; Drug: Mannitol Solution 325 mOsm/L; Diagnostic Test: Scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 76 mOsm/L Mannitol Solution 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.
Measured: 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
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.
Measured: 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
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.
Measured: At baseline and at 15-minute intervals beginning 30 minutes after ingestion through 180 minutes post-ingestion.
Secondary outcomes (9)
Peak Abdominal Pain Intensity Following 76 mOsm/L Mannitol Solution
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. The total score ranges from 24 to 120. Higher scores indicate greater pain intensity
Measured: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak Abdominal Pain Intensity Following 189 mOsm/L Mannitol Solution
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. The total score ranges from 24 to 120. Higher scores indicate greater pain intensity
Measured: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak Abdominal Pain Intensity Following 325 mOsm/L Mannitol Solution
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. The total score ranges from 24 to 120. Higher scores indicate greater pain intensity
Measured: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak Abdominal Pain Unpleasantness Following 76 mOsm/L Mannitol Solution
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. The total score ranges from 24 to 120. Higher scores indicate greater levels of pain unpleasantness.
Measured: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak Abdominal Pain Unpleasantness Following 189 mOsm/L Mannitol Solution
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. The total score ranges from 24 to 120. Higher scores indicate greater levels of pain unpleasantness.
Measured: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Peak Abdominal Pain Unpleasantness Following 325 mOsm/L Mannitol Solution
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. The total score ranges from 24 to 120. Higher scores indicate greater levels of pain unpleasantness.
Measured: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Change in Gastrointestinal Symptom Severity Following 76 mOsm/L Mannitol Solution
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.
Measured: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Change in Gastrointestinal Symptom Severity Following 189 mOsm/L Mannitol Solution
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.
Measured: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Change in Gastrointestinal Symptom Severity Following 325 mOsm/L Mannitol Solution
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.
Measured: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Sep 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Gut Brain InteractionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Jing (Iris) Wang, Mayo Clinic
- Investigators
- Xiao Jing Wang, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817706
- Sponsor's protocol ID
- 25-013906
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Noninvasive Metric to Measure Small Bowel Sensation - The Small Intestine Stress Test
- ClinicalTrials.gov ID
- NCT07817706
- Acronym / sponsor ID
- 25-013906
- Conditions
- Disorders of Gut Brain Interaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers Receiving Mannitol Solutions | Experimental | Drug: Mannitol Solution 76 mOsm/L, Drug: Mannitol Solution 189 mOsm/L, Drug: Mannitol Solution 325 mOsm/L, Diagnostic Test: ScintigraphyHealthy 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mannitol Solution 76 mOsm/LParticipants will ingest 500 mL of mannitol solution at 76 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit. | Drug | Healthy Volunteers Receiving Mannitol Solutions |
| Mannitol Solution 189 mOsm/LParticipants will ingest 500 mL of mannitol solution at 189 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit. | Drug | Healthy Volunteers Receiving Mannitol Solutions |
| Mannitol Solution 325 mOsm/LParticipants will ingest 500 mL of mannitol solution at 325 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit. | Drug | Healthy Volunteers Receiving Mannitol Solutions |
| ScintigraphyScintigraphy will be used to track gastric emptying, small bowel transit, and colonic filling of the radiolabeled mannitol solution during each testing visit. | Diagnostic test | Healthy Volunteers Receiving Mannitol Solutions |
Primary outcome
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.
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.
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.
9 secondary outcomes
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 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 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 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 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 Following 325 mOsm/L Mannitol Solution
Time frame: 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao Jing Wang, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mannitol Solution 76 mOsm/L, Mannitol Solution 189 mOsm/L and Mannitol Solution 325 mOsm/L in people with Disorders of Gut Brain Interaction, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor Hines (507-538-9959, hines.taylor@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.