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临床试验/NCT03569527
NCT03569527已完成不适用

Kiwifruit, Prunes, & Fiber for Abdominal and Bowel Symptoms in US Patients With Chronic Constipation

University of Michigan2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2018年6月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
2
主要终点
: Change in complete spontaneous bowel movement (CSBM)

研究概览

简要总结

This is a parallel group pilot study comparing the efficacy green kiwifruit, prunes or psyllium on abdominal and bowel related symptoms in US patients with chronic constipation patients.

详细描述

Chronic constipation and Irritable Bowel Syndrome with constipation are common gastrointestinal disorders which negatively impact quality of life, reduce work productivity, and account for significant direct and indirect costs. Patients with CC and IBS-C suffer with bowel symptoms such as reduced stool frequency, hard stool consistency, straining or a sensation of incomplete evacuation. Coupled with barriers which limit access to expensive prescription increasing concerns regarding the long-term safety of chronically dosed medications and, there has been an increasing demand for more "natural" solutions to a wide range of medical conditions, including CC and IBS-C. Green kiwifruit has long been used as a natural remedy to improve GI complaints. A growing body of literature supports the benefits of kiwifruit for gut health and in particular, abdominal discomfort and bowel regularity. In addition, patients are interested in dietary changes that could improve their symptoms The investigators propose a parallel group pilot study comparing the efficacy green kiwifruit, prunes or psyllium on abdominal and bowel related symptoms in US patients with chronic constipation patients. The investigators plan to recruit chronic constipation patients with or without pain. The total duration of the study will be 8 weeks (2- week baseline, 4-week intervention, and 2-week follow-up). Eligible patients will be randomized to receive kiwifruit (2 green kiwifruit per day, psyllium (12 g b.d./day, fiber=6g/day) or dried plums (50 g b.d., fiber=6 gm/day) for the 4 week intervention period. It is expected that Kiwifruit will offer greater efficacy than psyllium and prunes for abdominal and bowel symptoms in US patients with chronic constipation. This will be the first US data addressing the efficacy of Kiwifruit for abdominal and bowel symptoms in patients with chronic constipation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of functional constipation according to modified ROME IV diagnostic criteria*5b i. Must include two or more of the following:
  • Straining more than 25% of defecations
  • Lumpy or hard stools more than 25% of defecations
  • Sensation of incomplete evacuation more than 25% of defecations
  • Sensation of anorectal obstruction/blockage more than 25% of defecations
  • Manual manoeuvres to facilitate more than 25% of defecations (e.g. digital evacuation, support of pelvic floor)
  • Fewer than three defecations per week ii. Loose stools are rarely present without the use of laxatives * Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis For the purposes of this study, patients with abdominal pain will be included, but patients with severe pain (defined as average daily abdominal pain score of 7 or higher during the screening period) will be excluded. Patients with an appropriate level of GI symptoms despite taking stable doses (>3 months) of SSRI's, tricyclics or SNRIs will be allowed to enroll.

排除标准

  • Potential participants will be excluded if they have alarm features (GI bleeding, weight loss, unexplained iron deficiency anaemia, significant family history of colorectal cancer or IBD), anal fissures, significant chronic diseases (cardiovascular, cancer, renal failure, inflammatory bowel disease), previous gastrointestinal surgery (except appendectomy or cholecystectomy), neurological diseases (e.g. multiple sclerosis, spinal cord injury, CVA).
  • Patients taking opiates will not be eligible to participate. Women who are pregnant, breastfeeding or planning a pregnancy in the 2 months post selection (trial period) will be excluded.
  • As above, patients with severe IBS symptoms will be excluded (defined as average daily abdominal pain score of 7 or higher during the screening period).

研究组 & 干预措施

Kiwifruit

Active Comparator

Treating chronic constipation with 2 kiwifruit (6g fiber) per day

干预措施: Kiwifruit (Dietary Supplement)

Psyllium fiber

Active Comparator

Treating chronic constipation with 24g psyllium fiber (6g fiber) per day

干预措施: Fiber (Dietary Supplement)

Prune

Active Comparator

Treating chronic constipation with 100g dried plums (6g fiber) per day

干预措施: Prunes (Dietary Supplement)

结局指标

主要结局

: Change in complete spontaneous bowel movement (CSBM)

时间窗: 8 weeks

Complete spontaneous bowel movement will be recorded. This will be compared to the baseline, run-in periods, and follow-up period.

次要结局

  • abdominal discomfort(8 weeks)
  • bloating(8 weeks)
  • Change in SBM (spontaneous bowel movements)(8 weeks)
  • stool consistency(8 weeks)
  • straining(8 weeks)
  • abdominal pain(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shanti Eswaran

Clinical Associate Professor

University of Michigan

研究点 (2)

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