Development of a Noninvasive Metric to Measure Small Bowel Sensation - The Small Intestine Stress Test
8 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Taylor Hines
- Número de teléfono: 507-538-9959
- Correo electrónico: hines.taylor@mayo.edu
Ubicaciones de estudio
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Reclutamiento
- Mayo Clinic
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Contacto:
- Taylor Hines
- Número de teléfono: 507-538-9959
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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).
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Participants will ingest 500 mL of mannitol solution at 76 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
Participants will ingest 500 mL of mannitol solution at 189 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
Participants will ingest 500 mL of mannitol solution at 325 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
Scintigraphy will be used to track gastric emptying, small bowel transit, and colonic filling of the radiolabeled mannitol solution during each testing visit.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 76 mOsm/L Mannitol Solution Ingestion
Periodo de tiempo: At baseline and at 15-minute intervals beginning 30 minutes after ingestion through 180 minutes post-ingestion.
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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.
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At baseline and at 15-minute intervals beginning 30 minutes after ingestion through 180 minutes post-ingestion.
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Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 189 mOsm/L Mannitol Solution Ingestion
Periodo de tiempo: 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.
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At baseline and at 15-minute intervals beginning 30 minutes after ingestion through 180 minutes post-ingestion.
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Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 325 mOsm/L Mannitol Solution Ingestion
Periodo de tiempo: 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.
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At baseline and at 15-minute intervals beginning 30 minutes after ingestion through 180 minutes post-ingestion.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peak Abdominal Pain Intensity Following 76 mOsm/L Mannitol Solution
Periodo de tiempo: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
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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.
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Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
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Peak Abdominal Pain Intensity Following 189 mOsm/L Mannitol Solution
Periodo de tiempo: 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
|
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Peak Abdominal Pain Intensity Following 325 mOsm/L Mannitol Solution
Periodo de tiempo: 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.
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Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
|
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Peak Abdominal Pain Unpleasantness Following 76 mOsm/L Mannitol Solution
Periodo de tiempo: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
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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.
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Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
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Peak Abdominal Pain Unpleasantness Following 189 mOsm/L Mannitol Solution
Periodo de tiempo: 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.
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Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
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Peak Abdominal Pain Unpleasantness Following 325 mOsm/L Mannitol Solution
Periodo de tiempo: 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.
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Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
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Change in Gastrointestinal Symptom Severity Following 76 mOsm/L Mannitol Solution
Periodo de tiempo: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
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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.
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Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
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Change in Gastrointestinal Symptom Severity Following 189 mOsm/L Mannitol Solution
Periodo de tiempo: 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
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Change in Gastrointestinal Symptom Severity Following 325 mOsm/L Mannitol Solution
Periodo de tiempo: 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.
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Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Xiao Jing Wang, MD, Mayo Clinic
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
24 de agosto de 2026
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
30 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
8 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Publicado por primera vez (Actual)
14 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25-013906
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .