[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655925":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":46,"studyPopulation":46,"armGroups":53,"interventions":63,"overallOfficials":82,"centralContacts":86,"locations":92,"responsibleParty":108,"collaborators":46,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":46,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":46,"studyType":124,"phases":125,"briefSummary":126,"conditions":127,"keywords":46,"overallStatus":94,"whyStopped":46,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":46},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 76 mOsm\u002FL 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.","At baseline and at 15-minute intervals beginning 30 minutes after ingestion through 180 minutes post-ingestion.",{"measure":14,"description":11,"timeFrame":12},"Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 189 mOsm\u002FL Mannitol Solution Ingestion",{"measure":16,"description":11,"timeFrame":12},"Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 325 mOsm\u002FL Mannitol Solution Ingestion",[18,22,25,28,31,34,37,40,43],{"measure":19,"description":20,"timeFrame":21},"Peak Abdominal Pain Intensity Following 76 mOsm\u002FL Mannitol Solution","Peak abdominal pain intensity will be assessed after ingestion of 500 mL radiolabeled 76 mOsm\u002FL 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","Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion",{"measure":23,"description":24,"timeFrame":21},"Peak Abdominal Pain Intensity Following 189 mOsm\u002FL Mannitol Solution","Peak abdominal pain intensity will be assessed after ingestion of 500 mL radiolabeled 189 mOsm\u002FL 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",{"measure":26,"description":27,"timeFrame":21},"Peak Abdominal Pain Intensity Following 325 mOsm\u002FL Mannitol Solution","Peak abdominal pain intensity will be assessed after ingestion of 500 mL radiolabeled 325 mOsm\u002FL 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",{"measure":29,"description":30,"timeFrame":21},"Peak Abdominal Pain Unpleasantness Following 76 mOsm\u002FL Mannitol Solution","Peak abdominal pain unpleasantness will be assessed after ingestion of 500 mL radiolabeled 76 mOsm\u002FL 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.",{"measure":32,"description":33,"timeFrame":21},"Peak Abdominal Pain Unpleasantness Following 189 mOsm\u002FL Mannitol Solution","Peak abdominal pain unpleasantness will be assessed after ingestion of 500 mL radiolabeled 189 mOsm\u002FL 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.",{"measure":35,"description":36,"timeFrame":21},"Peak Abdominal Pain Unpleasantness Following 325 mOsm\u002FL Mannitol Solution","Peak abdominal pain unpleasantness will be assessed after ingestion of 500 mL radiolabeled 325 mOsm\u002FL 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.",{"measure":38,"description":39,"timeFrame":21},"Change in Gastrointestinal Symptom Severity Following 76 mOsm\u002FL Mannitol Solution","Gastrointestinal symptom severity will be assessed after ingestion of 500 mL radiolabeled 76 mOsm\u002FL 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.",{"measure":41,"description":42,"timeFrame":21},"Change in Gastrointestinal Symptom Severity Following 189 mOsm\u002FL Mannitol Solution","Gastrointestinal symptom severity will be assessed after ingestion of 500 mL radiolabeled 189 mOsm\u002FL 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.",{"measure":44,"description":45,"timeFrame":21},"Change in Gastrointestinal Symptom Severity Following 325 mOsm\u002FL Mannitol Solution","Gastrointestinal symptom severity will be assessed after ingestion of 500 mL radiolabeled 325 mOsm\u002FL 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.",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":46,"primaryPurpose":50,"observationalModel":46,"timePerspective":46,"maskingInfo":51},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":52,"maskingDescription":46,"whoMasked":46},"NONE",[54],{"label":55,"type":56,"description":57,"interventionNames":58},"Healthy Volunteers Receiving Mannitol Solutions","EXPERIMENTAL","Healthy adult volunteers will receive all three mannitol solution osmolarities-76 milliosmol (mOsm\u002FL), 189 mOsm\u002FL, and 325 mOsm\u002FL-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).",[59,60,61,62],"Drug: Mannitol Solution 76 mOsm\u002FL","Drug: Mannitol Solution 189 mOsm\u002FL","Drug: Mannitol Solution 325 mOsm\u002FL","Diagnostic Test: Scintigraphy",[64,69,73,77],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":46},"DRUG","Mannitol Solution 76 mOsm\u002FL","Participants will ingest 500 mL of mannitol solution at 76 mOsm\u002FL radiolabeled with 111Indium-DTPA during one testing visit.",[55],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":46},"Mannitol Solution 189 mOsm\u002FL","Participants will ingest 500 mL of mannitol solution at 189 mOsm\u002FL radiolabeled with 111Indium-DTPA during one testing visit.",[55],{"type":65,"name":74,"description":75,"armGroupLabels":76,"otherNames":46},"Mannitol Solution 325 mOsm\u002FL","Participants will ingest 500 mL of mannitol solution at 325 mOsm\u002FL radiolabeled with 111Indium-DTPA during one testing visit.",[55],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":46},"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.",[55],[83],{"name":84,"affiliation":5,"role":85},"Xiao Jing Wang, MD","PRINCIPAL_INVESTIGATOR",[87],{"name":88,"role":89,"phone":90,"phoneExt":46,"email":91},"Taylor Hines","CONTACT","507-538-9959","hines.taylor@mayo.edu",[93],{"facility":5,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":101,"coordinates":102},"Point",[103,104],-92.4699,44.02163,{"lat":104,"lon":103},[107],{"name":88,"role":89,"phone":90,"phoneExt":46,"email":46},{"type":85,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Xiao Jing (Iris) Wang","Principal Investigator","100655925","development-of-a-noninvasive-metric-to-measure-small-bowel-sensation---the-small-intestine-stress-test-100655925",false,"NCT07817706","Development of a Noninvasive Metric to Measure Small Bowel Sensation - The Small Intestine Stress Test","Inclusion Criteria:\n\n* No current gastrointestinal symptoms\n* No prior history of GI disorders, in particular DGBIs\n* Ability to provide informed consent\n* Ability to participate in study procedures\n* Absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results\n* For females, must not be pregnant or lactating due to radiation exposure.\n* Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control are permissible.\n\nExclusion Criteria\n\n* 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.\n* Patients with prior bowel surgery (not including appendectomy and cholecystectomy)\n* 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)",true,"ALL","18 Years","75 Years",{"count":122,"type":123},20,"ESTIMATED","INTERVENTIONAL",[48],"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.",[128],"Disorders of Gut Brain Interaction","2026-09-29",{"date":131,"type":132},"2026-10-02","ACTUAL",{"date":134,"type":132},"2026-09-01",{"date":136,"type":123},"2027-12-30",{"name":5,"class":6},1]