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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Taylor Hines
- 전화번호: 507-538-9959
- 이메일: hines.taylor@mayo.edu
연구 장소
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Minnesota
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Rochester, Minnesota, 미국, 55905
- 모병
- Mayo Clinic
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연락하다:
- Taylor Hines
- 전화번호: 507-538-9959
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 76 mOsm/L Mannitol Solution Ingestion
기간: 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. |
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
기간: 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
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak Abdominal Pain Intensity Following 76 mOsm/L Mannitol Solution
기간: 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. 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
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Peak Abdominal Pain Intensity Following 189 mOsm/L Mannitol Solution
기간: 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
기간: 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
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|
Peak Abdominal Pain Unpleasantness Following 76 mOsm/L Mannitol Solution
기간: 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. 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
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|
Peak Abdominal Pain Unpleasantness Following 189 mOsm/L Mannitol Solution
기간: 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
기간: 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
기간: 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. |
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
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Xiao Jing Wang, MD, Mayo Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-013906
개별 참가자 데이터(IPD) 계획
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