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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
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.
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGPeak 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.
Time frame: 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.
Time frame: 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.
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Scintigraphy will be used to track gastric emptying, small bowel transit, and colonic filling of the radiolabeled mannitol solution during each testing visit.
Time frame: At baseline and at 15-minute intervals beginning 30 minutes after ingestion through 180 minutes post-ingestion.
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. Higher scores indicate greater pain intensity.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion