Evidence map›Paper›PMID 31429811›Full record

ArticleTrials2019

Treatment of irritable bowel syndrome with diarrhoea using titrated ondansetron (TRITON): study protocol for a randomised controlled trial.

David Gunn, Ron Fried, Rabia Lalani, Amanda Farrin, Ivana Holloway, Tom Morris, Catherine Olivier, Rachael Kearns, Maura Corsetti, Mark Scott and 15 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 15 institutions in 2 countries.

David GunnNIHR Nottingham Digestive Diseases Biomedical Research Centre, University of Nottingham, Nottingham, UK.
Ron FriedBarts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Rabia LalaniWingate Institute of Neurogastroenterology, Queen Mary University of London, London, UK.
Amanda FarrinClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Ivana HollowayClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Tom MorrisClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Catherine OlivierClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Rachael KearnsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Maura CorsettiNottingham Digestive Diseases Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Mark ScottBarts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Adam FarmerRoyal Stoke Hospital, University Hospitals of North Midlands NHS Trust, Stoke, UK.
Anton EmmanuelUniversity College London Hospital, University College London Hospitals NHS Foundation Trust, London, UK.
Peter WhorwellWythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.
Yan YiannakouCounty Durham and Darlington Foundation Trust, University Hospital of North Durham, Durham, UK.
David SandersRoyal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
John MclaughlinSalford Royal NHS Foundation Trust, Salford Royal University Hospital, Manchester, UK.
Kapil KapurBarnsley Hospital, Barnsley Hospital NHS Foundation Trust, Barnsley, UK.
Maria EugenicosWestern General Hospital Edinburgh, NHS Lothian, Edinburgh, UK.
Ayesha AkbarLondon North West Healthcare NHS Trust, St Mark's Hospital, London, UK.
Nigel TrudgillSandwell General Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK.
Lesley HoughtonSt James's Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Phil G DinningDiscipline of Surgery and Gastroenterology, Flinders Medical Centre, Flinders University, Adelaide, South Australia, Australia.
Alexander C FordSt James's Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Qasim AzizBarts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Robin SpillerNIHR Nottingham Digestive Diseases Biomedical Research Centre, University of Nottingham, Nottingham, UK. robin.spiller@nottingham.ac.uk.ORCID http://orcid.org/0000-0001-6371-4500
University of Leeds · GBQueen Mary University of London · GBNottingham University Hospitals NHS Trust · GBLeeds Teaching Hospitals NHS Trust · GBBarnsley Hospital NHS Foundation Trust · GBCounty Durham and Darlington NHS Foundation Trust · GBFlinders University · AULondon North West Healthcare NHS Trust · GBManchester University NHS Foundation Trust · GBNHS Lothian · GBRoyal Hallamshire Hospital · GBSalford Royal NHS Foundation Trust · GBSandwell & West Birmingham Hospitals NHS Trust · GBUniversity College London Hospitals NHS Foundation Trust · GBUniversity Hospitals of North Midlands NHS Trust · GB

Funding

Department of Health EME/15/74/01Efficacy and Mechanism Evaluation Programme 15/74/01
6 · The paper itself

Abstract

backgroundIrritable bowel syndrome with diarrhoea (IBS-D) affects up to 4% of the general population. Symptoms include frequent, loose, or watery stools with associated urgency, resulting in marked reduction of quality of life and loss of work productivity. Ondansetron, a 5HT

methodsThis trial is a phase III, parallel group, randomised, double-blind, multi-centre, placebo-controlled trial, with embedded mechanistic studies. Participants (n = 400) meeting Rome IV criteria for IBS-D will be recruited from outpatient and primary care clinics and by social media to receive either ondansetron (dose titrated up to 24 mg daily) or placebo for 12 weeks. Throughout the trial, participants will record their worst abdominal pain, worst urgency, stool frequency, and stool consistency on a daily basis. The primary endpoint is the proportion of "responders" in each group, using Food and Drug Administration (FDA) recommendations. Secondary endpoints include pain intensity, stool consistency, frequency, and urgency. Mood and quality of life will also be assessed. Mechanistic assessments will include whole gut transit, faecal tryptase and faecal bile acid concentrations at baseline and between weeks 8 and 11. A subgroup of participants will also undergo assessment of sensitivity (n = 80) using the barostat, and/or high-resolution colonic manometry (n = 40) to assess motor patterns in the left colon and the impact of ondansetron. DISCUSSION: The TRITON trial aims to assess the effect of ondansetron across multiple centres. By defining ondansetron's mechanisms of action we hope to better identify patients with IBS-D who are likely to respond.

trial registrationISRCTN, ISRCTN17508514 , Registered on 2 October 2017.

Indexed as

AntidiarrhealsClinical Trials, Phase III as TopicDiarrheaDouble-Blind MethodHumansIrritable Bowel SyndromeMulticenter Studies as TopicOndansetronRandomized Controlled Trials as TopicSerotonin 5-HT3 Receptor AntagonistsTime FactorsTreatment OutcomeUnited KingdomAntidiarrhealsOndansetronSerotonin 5-HT3 Receptor AntagonistsBarostatDiarrhoeaHigh-resolution manometryIrritable bowel syndromeOndansetron

Identifiers

PMID31429811
PMCPMC6700805
OpenAlexW2969428984

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.