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Ondansetron for Indigestion and Diabetes Mellitus

This study is looking into why people with indigestion and diabetes experience stomach and gut symptoms. Researchers want to see if these symptoms are linked to how sensitive the small intestine is to nutrients. They are also studying a medication called ondansetron (8mg by mouth) to see how it affects these symptoms and gut function. You might be able to join if you are between 18 and 75 years old, healthy, and have symptoms of indigestion. The study will measure changes in your symptoms during specific tests and in your daily life over six weeks to see if ondansetron helps. The current status of this study is unclear, and it aims to enroll 150 participants.

Study design
This interventional study plans to enroll 150 participants. It will compare the effects of ondansetron (8mg) with a placebo (an inactive substance).
What's involved
You would participate in tests measuring symptom severity during an enteral infusion (up to 8 hours) and a gastric emptying study (up to 2 hours). You would also track your daily symptoms for six weeks.
Compensation
Not stated in the trial record.
Follow-up
Your daily symptoms will be measured for six weeks after baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03865290

Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Mayo Clinic
~150 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Ondansetron 8mgPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in severity of symptoms during enteral infusion
Measured over baseline, every 15 minutes up to 8 hours
+5 more outcomes measured

Conditions

Indigestion
Diabetes Mellitus

Explore related trials

Diabetes MellitusDyspepsia

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Adil E Bharucha, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Kelly J Feuerhak
[email protected]
507-255-6802
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Healthy male or non-pregnant, non-breastfeeding female volunteers;
18-75 years old;
Able to provide written informed consent before participating in the study
Able to communicate adequately with the investigator and to comply with the requirements for the entire study; including the willingness and ability to consume the components of the test meals
Symptoms of dyspepsia (i.e., early satiety, postprandial discomfort, nausea, vomiting, regurgitation)
Patients in the DM group will also require Type 1 or 2 DM of ≥ 3 years duration; in patients with type 2 DM, the dyspepsia symptoms should have begun or worsened after DM was diagnosed

Exclusion

Major abdominal surgery (i.e., appendectomy, cholecystectomy, tubal ligation, hysterectomy, herniorrhaphy, and limited colonic resection are permissible)
Clinical evidence (including physical exam and EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
Current use of opiates, alpha adrenergic agonists, metoclopramide, monoamine oxidase inhibitors, more than one serotonergic medication, and high doses of anticholinergic agents (eg, amitriptyline greater than 50 mg daily). If medically safe, these drugs may be discontinued for four half lives prior to study assessments.
Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain
Bleeding or clotting disorders or medications that increase risk of bleeding from mucosal biopsies
Positive tissue transglutaminase antibodies (TTG),
Pregnant or breast-feeding females
Known intolerance or allergy to eggs
Poor peripheral venous access, if central venous access is not available
Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study
History of Long QT Syndrome or prolonged QT interval (i.e., corrected QT interval \> 480 ms)
Current symptoms of a functional gastrointestinal disorder assessed by questionnaire
Severe vomiting that would preclude tube placement or participation in the study
Structural cause for symptoms by endoscopy within the past 12 months
Patients with gastric pacemakers

What this trial measures

  • Change in severity of symptoms during enteral infusionbaseline, every 15 minutes up to 8 hours

    Visual analog scale (VAS) used to measure the change in symptom severity with a scale of 0=absent, 1=light, 2=moderate, 3=severe, 4=intolerable

  • Change in severity of symptoms during gastric emptying studybaseline, every 15 minutes up to 2 hours

    Visual analog scale (VAS) used to measure the change in symptom severity with a scale of 0=absent, 1=light, 2=moderate, 3=severe, 4=intolerable

  • Change in severity of daily symptomsBaseline, daily for six weeks

    Gastroparesis Cardinal Symptom Index - Daily Diary (GCSI-DD) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe

  • Change in severity of gastrointestinal symptomsBaseline, 2 weeks, 6 weeks

    Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe

  • Change in severity of gastrointestinal symptoms effect on Quality of LifeBaseline, 2 weeks, 6 weeks

    Gastrointestinal Disorders - Quality of Life and Well-Being (PAGI-QOL) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe

  • Change in effect of Gastrointestinal symptoms on Quality of LifeBaseline

    Nepean Dyspepsia Index used to measure symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe