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Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea (MOLID)

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ClinicalTrials.gov Identifier: NCT03833999
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
This is a double-blind, two period, two treatment crossover trial of ondansetron verses placebo studying the effects of ondansetron in the small and large bowel, specifically its effects on the amount of water in the gut, measured by MRI.

Condition or disease Intervention/treatment Phase
Motility Disorder of Intestine Ondansetron Small Bowel Water Drug: Ondansetron 8mg Diagnostic Test: abdominal MRI Drug: Lactulose Drug: Placebo oral capsule Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: double-blind, two-period, two-treatment crossover trial
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Basic Science
Official Title: Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ondansetron and lactulose
Ondansetron 8mg three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging
Drug: Ondansetron 8mg
ondansetron, a 5HT3 receptor antagonist used clinically in nausea and vomiting

Diagnostic Test: abdominal MRI
serial MRIs on day 1 and day 3 of the study, at baseline and 2 hours apart 0-6 hours after meal ingestion on day 1 and 0-4 hours after the meal on day 3

Drug: Lactulose
Participants will receive 20mls lactulose twice daily for 48 hours prior to the third study day

Placebo Comparator: Placebo and lactulose
placebo oral capsule, one three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging
Diagnostic Test: abdominal MRI
serial MRIs on day 1 and day 3 of the study, at baseline and 2 hours apart 0-6 hours after meal ingestion on day 1 and 0-4 hours after the meal on day 3

Drug: Lactulose
Participants will receive 20mls lactulose twice daily for 48 hours prior to the third study day

Drug: Placebo oral capsule
overcoated placebo tablet, identical to the ondansetron




Primary Outcome Measures :
  1. small bowel water content [ Time Frame: 0-6 hours post meal ]
    Change from baseline in area under the curve (AUC) small bowel water content


Secondary Outcome Measures :
  1. small bowel motility (global motility score, arbitrary units) [ Time Frame: 2 and 4 hours postprandially ]
    Change from baseline motility over the study using cine MRI. An increased value indicates increased small bowel motility

  2. Weighted average position score (WAPS) [ Time Frame: baseline on day 3 ]
    MRI method of assessing colonic transit using MR marker pills ingested 12 hours before the scan. A lower value indicates faster whole gut transit

  3. T1 of the ascending colon (T1AC) [ Time Frame: baseline on day 3 ]
    MRI measure of water content in the ascending colon.Change from baseline in AUC T1AC from 0-4 hours. A higher value indicates more watery ascending colon content.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 18 or older
  • able to give informed consent

Exclusion Criteria:

  • Pregnancy declared by candidate
  • History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function, congenital long QT syndrome or QTc >450msecs for males or 470 msecs for female on screening ECG.
  • A positive diagnosis of irritable bowel syndrome based on the Rome IV criteria questionnaire
  • Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)
  • Intestinal stoma
  • Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner, known allergy to one of the food products
  • Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
  • Will not agree to dietary restrictions required during the MRI study day
  • Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
  • Inability to lie flat or exceed scanner limits of weight <120kg
  • Poor understanding of English language
  • Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM
  • Participation in any medical trials for the past 3 months
  • Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833999


Contacts
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Contact: David Gunn, BMBS 01157484187 david.gunn@nottingham.ac.uk

Locations
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United Kingdom
University of Nottingham Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Contact: David Gunn, BMBS    01159709966    david.gunn@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Robin Spiller University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03833999     History of Changes
Other Study ID Numbers: 85-1807
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans for sharing IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Nottingham:
ondansetron
small bowel water
Additional relevant MeSH terms:
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Intestinal Diseases
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Ondansetron
Lactulose
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents