Development of a Noninvasive Metric to Measure Small Bowel Sensation - The Small Intestine Stress Test
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Taylor Hines
- Número de telefone: 507-538-9959
- E-mail: hines.taylor@mayo.edu
Locais de estudo
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Recrutamento
- Mayo Clinic
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Contato:
- Taylor Hines
- Número de telefone: 507-538-9959
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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). |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 76 mOsm/L Mannitol Solution Ingestion
Prazo: 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
Prazo: 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
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Peak Abdominal Pain Intensity Following 76 mOsm/L Mannitol Solution
Prazo: 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. 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
|
|
Peak Abdominal Pain Intensity Following 189 mOsm/L Mannitol Solution
Prazo: 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. 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
|
|
Peak Abdominal Pain Intensity Following 325 mOsm/L Mannitol Solution
Prazo: 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. 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
|
|
Peak Abdominal Pain Unpleasantness Following 76 mOsm/L Mannitol Solution
Prazo: 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. The total score ranges from 24 to 120. Higher scores indicate greater levels of 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
Prazo: 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. The total score ranges from 24 to 120. Higher scores indicate greater levels of 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
Prazo: 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. The total score ranges from 24 to 120. Higher scores indicate greater levels of 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Xiao Jing Wang, MD, Mayo Clinic
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Outros números de identificação do estudo
- 25-013906
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