HVN COMFORT-PSYKI Metadata Record - The Christchurch IBS cohort to investigate mechanisms for gut relief and improved transit - Psyllium and Kiwifruit translation study

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

本元数据记录及其附属文件阐明了本研究采集的各类数据，并制定了该数据当前及未来的管理政策。研究描述：本旨在探究肠道症状缓解与肠道转运功能改善机制的克赖斯特彻奇肠易激综合征（Irritable Bowel Syndrome, IBS）队列研究（COMFORT）于2016年启动，采用系统性研究方法采集涵盖临床、心理、生物学以及创新性膳食在内的多维度数据。我们认为，COMFORT研究采用的研究方法，是评估食物作为功能性胃肠病（Functional Gastrointestinal Disorders, FGIDs）治疗方案的理想基础。为验证这一设想，本研究设计了为期最长16周的随机交叉试验：每日摄入2个SunGold™猕猴桃，并将其与膳食纤维配比匹配的欧车前制剂进行对照，每项干预周期为3至4周。本研究假设，两项干预措施均可改善便秘型肠易激综合征（Irritable Bowel Syndrome with Constipation, IBS-C）与功能性便秘（Functional Constipation, FC）人群中经胃肠症状评分量表（Gastrointestinal Symptom Rating Scale, GSRS）评估的胃肠道症状，并提升排便频次。此外，本研究还期望探究不同受试者分组与干预措施下，受试者肠道微生物组与代谢组所呈现的差异。