HVN KINGS GASTRIC Metadata Record - Kiwifruit Ingestion to Normalise Gut Symptoms (Gastric) in individuals with Functional Constipation (FC) or Constipation-predominant Irritable Bowel Syndrome (IBS-C)

Version 2 2023-09-14, 00:57

Version 1 2023-09-13, 00:36

dataset

posted on 2023-09-14, 00:57 authored by Nicole Roy, Richard Gearry

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 Kiwifruit Ingestion to Normalise Gut Symptoms (KINGS) study was launched to understand more about the clinical, psychological, biological, and dietary changes in individuals with Functional Constipation (FC) or Constipation-Predominant Irritable Bowel Syndrome (IBS/C). We believe that the approach used in this study can help generate new knowledge beyond that already reported for the consumption of green kiwifruit. The Auckland KINGS Gastric is a second locality for the KINGS in the Christchurch IBS cohort (ACTRN12621000621819), with site-specific study design and secondary outcomes. In this single arm, open-label, intervention study, we aim to assess the impact of habitual consumption of two Green Kiwifruit daily for 4 weeks on abdominal pain, bowel habits and other gastrointestinal symptoms in individuals with FC/IBS-C; and to evaluate the effects of habitual consumption of Green Kiwifruit on digestive function and biomarkers of these physiological effects. Additionally, we hope to investigate the influence of the two Green Kiwifruit intervention on the microbiome and metabolome, and to compare differences between individuals with constipation and healthy controls. The trial will be a maximum of up to 8 weeks in total.

History

Publisher

University of Auckland

Contact

nicole.roy@otago.ac.nz

Temporal coverage: start

2022-08-15

HVN Project / Programme Name

HVN KINGS GASTRIC

Data access requirements

No sharing of individual participant data. Access to aggregate data may be possible, please contact the data champion and Maori data champion for questions around access to the data.

Principal investigator organisation

University of Otago, Christchurch

Collaborating researchers and affiliations

Principal Investigators: Professor Richard Gearry, Department of Medicine, University of Otago, Christchurch Professor Nicole Roy, Department of Human Nutrition, University of Otago Co-ordinating Investigator (Auckland Site): Dr Amber Milan, The Liggins Institute, The University of Auckland / Physiology & Health Team; AgResearch Limited Research coordinator: Dr Simone Bayer, PhD, Department of Medicine, Gastrointestinal Unit for Translational Studies, University of Otago, Christchurch Clinical coordinator (Auckland Site): Dr Julia Cree, The Liggins Institute, The University of Auckland, Auckland Project Team: Professor Warren McNabb (Riddet Institute) Dr Karl Fraser (AgResearch) Dr Jane Mullaney (AgResearch) Professor Robin Spiller (National Institute of Health Research (NIHR) Nottingham Biomedical Research Centre) Dr Janine Cooney (Plant & Food Research) Dr Olivier Gasser (Malaghan Institute of Medical Research) Dr Matthew Barnett (AgResearch) Professor Richard Mithen (Liggins Institute)

Data description

Outcomes of the Study and associated data Primary outcome An improvement of digestive comfort indicated by statistically significant abdominal pain relief as measured by the abdominal pain domain of the Gastrointestinal Symptom Rating Scale (GSRS) Associated data: Gastrointestinal Symptom Rating Scale (GSRS) Questionnaire Secondary outcomes 1. Clinical outcomes - An increase in Complete Spontaneous Bowel Movements (CSBM) in FC/IBSC with the GrKF intervention - Improved scores of validated PROs detailing the subjective assessment of digestive health parameters, and general wellbeing Associated data: ROME IV Diagnostic Questionnaire, Daily Bowel Habit Diary, Three-day food diary, Fibre-Specific Food Frequency Questionnaire – FFQ, Structured Assessment of Gastrointestinal Symptoms Questionnaire, Patient Reported Outcomes Measurement Information System (PROMIS) Survey, Irritable Bowel Syndrome-Quality of Life Survey, Visual Analogue Scales for digestive comfort (postprandial symptoms) and appetite 2. Systems biology outcomes - Changes in faecal metabolome, bile and organic acid production and plasma metabolome after intervention Associated data: Plasma Metabolome, Faecal Metagenome – DNASeq, Faecal Metabolome, Faecal Organic and Bile Acids 3. Physiome outcomes - Changes in digestive function as measured by BSGM Associated data: Body gastric surface mapping – BSGM Other data: Participant screening data and information sheet, Modified Hunter New England Health Survey – ModHNES, Economic Living Standard Index short form – ELSISF (Demographics)