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)

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.

本元数据记录及其所附文件对本研究收集的数据种类进行了陈述，并规定了当前及未来对该数据的治理政策。描述：金奇异果摄入以规范胃肠症状（KINGS）研究旨在深入了解功能性便秘（FC）或便秘型肠易激综合症（IBS/C）患者的临床、心理、生物和饮食变化。我们相信，本研究采用的方法有助于生成关于绿奇异果消费的新知识，超越已有报道。奥克兰KINGS胃部研究是基督城IBS队列（ACTRN12621000621819）的第二个研究地点，具有特定研究设计和次要结果。在这项单臂、开放标签、干预性研究中，我们的目标是评估每日习惯性摄入两个绿奇异果4周对FC/IBS-C患者腹部疼痛、肠道习惯和其他胃肠道症状的影响；并评估习惯性摄入绿奇异果对消化功能和生理效应的生物标志物的影响。此外，我们希望探究两个绿奇异果干预对微生物组和代谢组的影响，并比较便秘患者与健康对照之间的差异。试验总时长最多为8周。