This metadata record and it's attached files make statements about the kinds of data collected as part of this research, and set out policies for governance of that data, now and in the future.
Description: The Christchurch IBS cohort to investigate mechanisms for gut relief and improved transit (COMFORT) was launched in 2016 as a systems approach to gain a wide range of clinical, psychological, biological, and, as a novelty, dietary data. We believe that the approach used by the COMFORT study is the ideal basis to evaluate food as treatment options in FGIDs.
To test this, we have chosen two SunGold (TM) Kiwifruit a day and compare this with a fibre matched psyllium preparation in a randomized cross-over study over the course of a maximum of 16 weeks, with each intervention being between 3 and 4 weeks long. We hypothesise that the Interventions will improve gastrointestinal symptoms as assessed by GSRS ratings in the FC/IBS-C group, as well as increase bowel movements. Additionally, we hope to find differences in microbiome and metabolome depending on the participant groups and interventions
Publisher
University of AucklandTemporal coverage: start
2018-01-01HVN Project / Programme Name
HVN COMFORT-PSYKIData access requirements
Individual data is not available for the public. It would be a breach of data security.Principal investigator organisation
University of Otago, ChristchurchCollaborating researchers and affiliations
Principal Investigators:
Richard Gearry, Department of Medicine, University of Otago, Christchurch
Simone Bayer, Department of Medicine, University of Otago, Christchurch
Associate Investigators:
Nicole Roy (University of Otago)
Phoebe Heenan (University of Otago)
Chris Frampton (University of Otago)
Wayne Young (AgResearch)
Karl Fraser (AgResearch)
Janine Cooney (Plant and Food Research)
Diana Cabrera (AgResearch)
Catherine Wall (University of Otago)
Lynley Drummond (Drummond Food Science Advisory Ltd.)Data description
Outcomes of the study and associated data
Co-Primary Clinical outcomes
- Feasibility
- Change in the Gastrointestinal Symptom Rating Scale Constipation Domain Scores
Associated data: Recruitment rate, drop-out rate, protocol adherence data, gastrointestinal symptoms rating score (GSRS)
Secondary outcomes
- Complete Daily Bowel Movement per week
- Ease of Defecation
- Adverse Events
Associated data: Daily bowel habit diary, modified patient reported outcomes measurement information system (PROMIS) questionnaires, structured assessment of gastrointestinal symptoms (SAGIS) questionnaire, adverse events data
Other outcomes and associated data: Breath metabolomics, blood metabolomics, blood plasma neuromarkers, blood plasma immune markers, blood plasma vitamin C, faecal targeted metabolomics, faecal untargeted metabolomics, faecal metagenomics, urine metabolomicsPrincipal investigator contact email
richard.gearry@otago.ac.nz
