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

29. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Rekruttering
        • Mayo Clinic
        • Ta kontakt med:
          • Taylor Hines
          • Telefonnummer: 507-538-9959

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Legemiddel: 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.

Legemiddel: 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.

Legemiddel: 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.

Diagnostisk test: Scintigraphy

Scintigraphy will be used to track gastric emptying, small bowel transit, and colonic filling of the radiolabeled mannitol solution during each testing visit.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peak Gastrointestinal Symptom Severity During Small Bowel Transit Following 76 mOsm/L Mannitol Solution Ingestion
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peak Abdominal Pain Intensity Following 76 mOsm/L Mannitol Solution
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mayo Clinic

Etterforskere

  • Hovedetterforsker: Xiao Jing Wang, MD, Mayo Clinic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2026

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. desember 2027

Datoer for studieregistrering

Først innsendt

8. september 2026

Først innsendt som oppfylte QC-kriteriene

8. september 2026

Først lagt ut (Faktiske)

14. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25-013906

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

produkt produsert i og eksportert fra USA

Nei

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