Development of a Noninvasive Metric to Measure Small Bowel Sensation - The Small Intestine Stress Test
8. září 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Podmínky
Typ studie
Intervenční
Zápis (Odhadovaný)
20
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Taylor Hines
- Telefonní číslo: 507-538-9959
- E-mail: hines.taylor@mayo.edu
Studijní místa
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Minnesota
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Rochester, Minnesota, Spojené státy, 55905
- Nábor
- Mayo Clinic
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Kontakt:
- Taylor Hines
- Telefonní číslo: 507-538-9959
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 76 mOsm/L Mannitol Solution Ingestion
Časové okno: 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
Časové okno: 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.
|
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Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 325 mOsm/L Mannitol Solution Ingestion
Časové okno: 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.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Peak Abdominal Pain Intensity Following 76 mOsm/L Mannitol Solution
Časové okno: 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.
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
Časové okno: 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
|
|
Peak Abdominal Pain Intensity Following 325 mOsm/L Mannitol Solution
Časové okno: 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.
|
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
Časové okno: 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.
|
Baseline, then every 15 minutes from 30 minutes through 180 minutes after ingestion
|
|
Peak Abdominal Pain Unpleasantness Following 189 mOsm/L Mannitol Solution
Časové okno: 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.
|
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
Časové okno: 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.
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Xiao Jing Wang, MD, Mayo Clinic
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
24. srpna 2026
Primární dokončení (Odhadovaný)
30. června 2027
Dokončení studie (Odhadovaný)
30. prosince 2027
Termíny zápisu do studia
První předloženo
8. září 2026
První předloženo, které splnilo kritéria kontroly kvality
8. září 2026
První zveřejněno (Aktuální)
14. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
14. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. září 2026
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 25-013906
Plán pro data jednotlivých účastníků (IPD)
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Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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produkt vyrobený a vyvážený z USA
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