NCT06319755招募中不适用
Characteristics of Intestinal Microbiome Following Pancreatic Surgery - a Prospective Case Controlled Exploratory Study
Royal Prince Alfred Hospital, Sydney, Australia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Comparison of microbiota profile between post-surgical participants and healthy controls.
研究概览
简要总结
The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls.
The primary objectives of the study are:
- To explore and describe any differences in the gut microbiota especially Shannon diversity index
- To conduct functional profiling by exploring and describing any differences in functional metabolites produced in the gut in people having had pancreatoduodenectomy greater than 6 months ago compared to healthy matched controls.
Participants will be asked to complete the following:
- Three-day food, bowel and medication diary (see Protocol appendix 5)
- Gastrointestinal Symptom Rating Scale (see Protocol appendix 6)
- Quality of life questionnaire (see Protocol appendix 7)
- Stool sample test using Microba Insight TradeMark (a small swab is taken from soiled toilet paper, sealed in a room-temperature storage capsule and mailed to the testing laboratory)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (aged equal to or greater than 18 years) having had pancreatoduodenectomy (Whipple's) surgery between April 2018 - December 2023 for curative intent and received post-operative clinical management at Royal Prince Alfred Hospital, (post-surgical participants), and
- •Healthy adults matched by age, sex, body mass index and smoking status
排除标准
- •Aged less than 18 years
- •Are unable to complete the questionnaires or testing due to language or cognitive limitations
- •Have active or recurring pancreatic cancer, or where the surgery was for non-curative intent
- •Have other gastrointestinal conditions that could affect gut symptoms or microbiome such as Inflammatory Bowel disease, Irritable Bowel Syndrome Coeliac disease, or are currently pregnant or breastfeeding
- •Are currently taking medications or diet that can affect gut symptoms or microbiome
结局指标
主要结局
Comparison of microbiota profile between post-surgical participants and healthy controls.
时间窗: During data collection, 3 days
Stool samples will be analysed to compare the Shannon diversity index (calculated by taking the number of each microbial species, the proportion each species is of the total number of individuals, summed by the proportion times the natural log of the proportion for each species) between participant groups.
次要结局
- Pre-paid return rates(From enrollment to the collection of data from participants, 3 days)
- Ease of matching(Enrollment period, up to 12 months)
- Compliance with 3-day food dairies(From enrollment to the collection of data from participants, 3 days)
- Gastrointestinal symptoms(During data collection period, 3 days)
- Protein:fibre ratio of diet(During data collection period, 3 days)
- Shannon diversity index(During data collection period, 3 days)
研究者
Dale Palmer
Clinical Dietitian
Royal Prince Alfred Hospital, Sydney, Australia
研究点 (1)
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