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Development of a Noninvasive Metric to Measure Small Bowel Sensation - The Small Intestine Stress Test

8. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Minnesota
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • Rekrutierung
        • Mayo Clinic
        • Kontakt:
          • Taylor Hines
          • Telefonnummer: 507-538-9959

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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).
Arzneimittel: Mannitol Solution 76 mOsm/L
Participants will ingest 500 mL of mannitol solution at 76 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
Arzneimittel: Mannitol Solution 189 mOsm/L
Participants will ingest 500 mL of mannitol solution at 189 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
Arzneimittel: Mannitol Solution 325 mOsm/L
Participants will ingest 500 mL of mannitol solution at 325 mOsm/L radiolabeled with 111Indium-DTPA during one testing visit.
Diagnosetest: Scintigraphy
Scintigraphy will be used to track gastric emptying, small bowel transit, and colonic filling of the radiolabeled mannitol solution during each testing visit.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 76 mOsm/L Mannitol Solution Ingestion
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Peak Abdominal Pain Intensity Following 76 mOsm/L Mannitol Solution
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Peak Abdominal Pain Unpleasantness Following 76 mOsm/L Mannitol Solution
Zeitfenster: 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. 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
Zeitfenster: 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
Peak Abdominal Pain Unpleasantness Following 325 mOsm/L Mannitol Solution
Zeitfenster: 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
Change in Gastrointestinal Symptom Severity Following 76 mOsm/L Mannitol Solution
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mayo Clinic

Ermittler

  • Hauptermittler: Xiao Jing Wang, MD, Mayo Clinic

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

24. August 2026

Primärer Abschluss (Geschätzt)

30. Juni 2027

Studienabschluss (Geschätzt)

30. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

8. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. September 2026

Zuerst gepostet (Tatsächlich)

14. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 25-013906

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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