Motility Disorder of IntestinePhase 4MOLIDNCT03833999
Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea
A Phase 4 study testing Ondansetron 8mg, abdominal MRI and Lactulose in people with Motility Disorder of Intestine and Ondansetron, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motility Disorder of Intestine, Ondansetron, Small Bowel Water
- What is being tested?
- Ondansetron 8mg, abdominal MRI and Lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2018to 27 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 or older
- able to give informed consent
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG7 2UH
About this study
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.
Read the detailed description
If participants interested to take part the investigators will ask some questions to check participants are eligible to take part. Part of this involves measuring height, weight and having an electrocardiogram (ECG) to assess the heart. This is non-invasive and is achieved by attaching stickers across participants' chest. If participants are eligible the investigators will invite them to join the study, asked to sign a consent form and arrange for them to come to 4 study days.
Study Days The study days take place at the 3T Acheiva MRI scanner at the Sir Peter Mansfield Imaging Centre. This is located on the University Park campus.
The day before each scanning day participants will be asked to eat and drink as normal, avoiding beans or pulses and abstain from alcohol. The investigators ask that participants avoid strenuous exercise, and if they smoke to continue as normal.
On the morning of the day 1 of the study participants should come to the MRI scanner around 8 o'clock in the morning. They should not have anything to eat or drink at all, unless they need a sip of water to swallow essential medicines. The investigators will confirm that it is still safe for participants to be scanned and participants will then change into surgical scrubs (provided) to begin the study.
Participants will be randomly assigned to take either ondansetron, the anti-sickness tablet, for the first 2 visits or a dummy tablet (placebo) three times daily. They will be overcoated tablets so that neither participants nor the research team can tell which one it is.
Participants will then have an MRI scan, during which the investigators will scan the body in different ways. A separate information sheet tells participants more about this.
After these are done the investigators will give participants a meal supplement drink called Fortisip. Participants will have around 10 minutes to finish the drink. As soon as participants finish the MRI will be repeated. Participants will then have 3 further MRI scans, 2, 4 and 6 hours after the meal. After the last scan the investigators will give participants another dose of either the ondansetron or the placebo, and 20mls of a laxative called lactulose. The investigators will provide participants with tablets and the laxative for the following day at home.
Day 2 of the study participants can have a normal day at home, however the investigators ask that participants refrain from strenuous exercise, avoid alcohol, beans and pulses and continue a usual smoking habit if applicable. Participants are asked to take the tablet (either ondansetron or placebo) three times a day (in the morning, midday and evening) and 20mls of the laxative in the morning and evening. They are also asked to take 5 MRI marker tablets at 8pm, and take a timestamped photo or video so the investigators can ensure these are taken at the correct time. The marker tablets will be used to measure the speed of food along the gut on the scan on day 3.
On day 3 participants are asked to return for another day of scanning at the Sir Peter Mansfield Imagine Centre. Again, participants should come to the MRI scanner around 8 o'clock in the morning. They should not have anything to eat or drink at all, unless a sip of water is needed to swallow essential medicines. The investigators will re-confirm that it is still safe for participants to be scanned and participants will then change into surgical scrubs (provided) to begin the study.
Participants will receive a further dose of the ondansetron or placebo tablet, then have an MRI scan before drinking the same Fortisip meal supplement and the lactulose. Once participants have finished the drink they will have 2 further MRI scans, 2 and 4 hours after the meal. Participants can then leave for the day.
The investigators ask that participants come back to repeat the above 3 day procedure once more, taking the alternative tablet the second time around. Study periods will normally be one week apart. It is very important that participants attend both study periods as the investigators will compare the results from one week to the other.
- Being tested
- Ondansetron 8mg, abdominal MRI, Lactulose, Placebo oral capsule
- Keywords
- ondansetron, small bowel water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 8mgDrug
ondansetron, a 5HT3 receptor antagonist used clinically in nausea and vomiting
abdominal MRIDiagnostic test
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
LactuloseDrug
Participants will receive 20mls lactulose twice daily for 48 hours prior to the third study day
Placebo oral capsuleDrug
overcoated placebo tablet, identical to the ondansetron
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron and lactulose | Experimental | Ondansetron 8mg three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging Receives: Drug: Ondansetron 8mg; Diagnostic Test: abdominal MRI; Drug: Lactulose |
| Placebo and lactulose | Placebo comparator | placebo oral capsule, one three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging Receives: Diagnostic Test: abdominal MRI; Drug: Lactulose; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
small bowel water content
Change from baseline in area under the curve (AUC) small bowel water content
Measured: 0-6 hours post meal
Secondary outcomes (3)
small bowel motility (global motility score, arbitrary units)
Change from baseline motility over the study using cine MRI. An increased value indicates increased small bowel motility
Measured: 2 and 4 hours postprandially
Weighted average position score (WAPS)
MRI method of assessing colonic transit using MR marker pills ingested 12 hours before the scan. A lower value indicates faster whole gut transit
Measured: baseline on day 3
T1 of the ascending colon (T1AC)
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.
Measured: baseline on day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start16 Oct 2018
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motility Disorder of IntestineStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blind, two-period, two-treatment crossover trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Spiller, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833999
- Sponsor's protocol ID
- 85-1807
- Acronym
- MOLID
- Status last verified
- Feb 2019
- First submitted
- 7 Jan 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans for sharing IPD
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea
- ClinicalTrials.gov ID
- NCT03833999
- Acronym / sponsor ID
- MOLID / 85-1807
- Keywords
- ondansetron, small bowel water
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
If participants interested to take part the investigators will ask some questions to check participants are eligible to take part. Part of this involves measuring height, weight and having an electrocardiogram (ECG) to assess the heart. This is non-invasive and is achieved by attaching stickers across participants' chest. If participants are eligible the investigators will invite them to join the study, asked to sign a consent form and arrange for them to come to 4 study days.
Study Days The study days take place at the 3T Acheiva MRI scanner at the Sir Peter Mansfield Imaging Centre. This is located on the University Park campus.
The day before each scanning day participants will be asked to eat and drink as normal, avoiding beans or pulses and abstain from alcohol. The investigators ask that participants avoid strenuous exercise, and if they smoke to continue as normal.
On the morning of the day 1 of the study participants should come to the MRI scanner around 8 o'clock in the morning. They should not have anything to eat or drink at all, unless they need a sip of water to swallow essential medicines. The investigators will confirm that it is still safe for participants to be scanned and participants will then change into surgical scrubs (provided) to begin the study.
Participants will be randomly assigned to take either ondansetron, the anti-sickness tablet, for the first 2 visits or a dummy tablet (placebo) three times daily. They will be overcoated tablets so that neither participants nor the research team can tell which one it is.
Participants will then have an MRI scan, during which the investigators will scan the body in different ways. A separate information sheet tells participants more about this.
After these are done the investigators will give participants a meal supplement drink called Fortisip. Participants will have around 10 minutes to finish the drink. As soon as participants finish the MRI will be repeated. Participants will then have 3 further MRI scans, 2, 4 and 6 hours after the meal. After the last scan the investigators will give participants another dose of either the ondansetron or the placebo, and 20mls of a laxative called lactulose. The investigators will provide participants with tablets and the laxative for the following day at home.
Day 2 of the study participants can have a normal day at home, however the investigators ask that participants refrain from strenuous exercise, avoid alcohol, beans and pulses and continue a usual smoking habit if applicable. Participants are asked to take the tablet (either ondansetron or placebo) three times a day (in the morning, midday and evening) and 20mls of the laxative in the morning and evening. They are also asked to take 5 MRI marker tablets at 8pm, and take a timestamped photo or video so the investigators can ensure these are taken at the correct time. The marker tablets will be used to measure the speed of food along the gut on the scan on day 3.
On day 3 participants are asked to return for another day of scanning at the Sir Peter Mansfield Imagine Centre. Again, participants should come to the MRI scanner around 8 o'clock in the morning. They should not have anything to eat or drink at all, unless a sip of water is needed to swallow essential medicines. The investigators will re-confirm that it is still safe for participants to be scanned and participants will then change into surgical scrubs (provided) to begin the study.
Participants will receive a further dose of the ondansetron or placebo tablet, then have an MRI scan before drinking the same Fortisip meal supplement and the lactulose. Once participants have finished the drink they will have 2 further MRI scans, 2 and 4 hours after the meal. Participants can then leave for the day.
The investigators ask that participants come back to repeat the above 3 day procedure once more, taking the alternative tablet the second time around. Study periods will normally be one week apart. It is very important that participants attend both study periods as the investigators will compare the results from one week to the other.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blind, two-period, two-treatment crossover trial
| Arm | Type | Receives |
|---|---|---|
| Ondansetron and lactulose | Experimental | Drug: Ondansetron 8mg, Diagnostic Test: abdominal MRI, Drug: LactuloseOndansetron 8mg three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging |
| Placebo and lactulose | Placebo comparator | Diagnostic Test: abdominal MRI, Drug: Lactulose, Drug: Placebo oral capsuleplacebo oral capsule, one three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18 or older
- able to give informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron 8mgondansetron, a 5HT3 receptor antagonist used clinically in nausea and vomiting | Drug | Ondansetron and lactulose |
| abdominal MRIserial 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 | Diagnostic test | Ondansetron and lactulose, Placebo and lactulose |
| LactuloseParticipants will receive 20mls lactulose twice daily for 48 hours prior to the third study day | Drug | Ondansetron and lactulose, Placebo and lactulose |
| Placebo oral capsuleovercoated placebo tablet, identical to the ondansetron | Drug | Placebo and lactulose |
Primary outcome
small bowel water content
Time frame: 0-6 hours post meal
Change from baseline in area under the curve (AUC) small bowel water content
3 secondary outcomes
small bowel motility (global motility score, arbitrary units)
Time frame: 2 and 4 hours postprandially
Weighted average position score (WAPS)
Time frame: baseline on day 3
T1 of the ascending colon (T1AC)
Time frame: baseline on day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Individual participant dataSharing planned: No. No plans for sharing IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Spiller principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron 8mg, abdominal MRI and Lactulose in people with Motility Disorder of Intestine and Ondansetron, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
small bowel water content (time frame: 0-6 hours post meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.