Development of a Noninvasive Metric to Measure Small Bowel Sensation - The Small Intestine Stress Test
8. 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
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
- Navn: Taylor Hines
- Telefonnummer: 507-538-9959
- E-post: hines.taylor@mayo.edu
Studiesteder
-
-
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
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).
|
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.
|
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.
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.
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.
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.
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
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.
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
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.
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
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
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 (Antatt)
24. august 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)
14. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. 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)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .