ACTRN12621000621819尚未招募未知
A single blinded, negative controlled, randomised, parallel design study to determine if kiwifruit Ingestion can normalise gastrointestinal symptoms in individuals with Functional Constipation (FC) or Constipation-predominant Irritable Bowel Syndrome (IBS-C).
icole Roy0 个研究点目标入组 60 人开始时间: 2021年5月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Adult with FC or IBS-C (18-65 years) with a BMI between 18 and 35kg/m2.
- •A. The FC participants will be selected based on the following criteria:
- •Presence of FC according to Rome IV Diagnostic Criteria (fulfilled for the last three months with symptom onset at least six months prior to diagnosis):
- •1. Must include two or more of the following:
- •- Straining during more than 25% of defecations
- •- Lumpy or hard stools during more than 25% of defecations
- •- Sensation of incomplete evacuation for more than 25% of defecations
- •- Sensation of anorectal obstructions/blockage for more than 25% of defecations
- •- Manual manoeuvres to facilitate more than 25% of defecations (e.g. digital evacuation, support of the pelvic floor)
- •- Fewer than three complete spontaneous bowel movements per week
- •2. Loose stools are rarely present without the use of laxatives
- •3. Insufficient criteria for irritable bowel syndrome
- •The participants with mild IBS-C will be selected based on the following Rome IV Diagnostic Criteria (fulfilled for the last three months with symptom onset at least six months prior to diagnosis):
- •1. Recurrent abdominal pain, on average, at least one day per week in the last three months, associated with two or more of the following:
- •- Related to defecation
- •- Associated with a change in frequency of stool
- •- Associated with a change in form (appearance) of stool
- •2. More than 25% of bowel movements with Bristol Stool form types 1 or 2 and less than 25% of Bowel movements of types 6 or 7.
排除标准
- •- Inability to give informed consent
- •- Pregnancy, breastfeeding or planning a pregnancy in the three months post-selection (study time frame)
- •- Alarm features associated with bowel habits, such as recent changes in bowel habits (onset less than three months), rectal bleeding, sudden weight loss, occult blood in stool, anaemia, anal fissures, bleeding haemorrhoids, and family history of gastrointestinal cancer at a young age or Irritable Bowel Disease (IBD)
- •- Known significant gastrointestinal disorder and disease other than IBS-C, diverticulitis, coeliac disease, IBS-D or mixed IBS, or previous bowel resection.
- •- Known systemic disease that could influence the gut directly or through medication use (e.g. diabetes, opiate or NSAID use)
- •- Chronic disease such as cardiovascular, cancer, renal failure, previous gastrointestinal surgery other than cholecystectomy or appendectomy, neurological conditions such as multiple sclerosis, spinal cord injury, or stroke
- •- Fasting blood glucose equals to or more than 6.0 mmol/l
- •- Known kiwifruit or latex allergy
- •- Inability to swallow pills
- •- Inability to access MRI machines such as presence of pacemakers or cochlear implants
- •- Laxative use and inability or unwillingness to stop laxative use for the seven days before sample collections.
- •- An IBS Severity Index score of over 300.
- •- Indication of inability to comply with the study procedures
研究者
相似试验
进行中（未招募）
1 期
A study evaluating the effect of EVARREST™ Fibrin Sealant Patch ascompared to Tachosil in controlling bleeding during cardivascular surgeryEUCTR2013-003464-31-GBEthicon Inc210
进行中（未招募）
不适用
A study evaluating the effect of EVARREST™ Fibrin Sealant Patch ascompared to TachoSil in controlling bleeding during cardivascular surgerysubjects undergoing major aortic surgery, including ascending,arch, or descending aorta replacement, requiring adjunctive support forhemostasis at the anastomotic suture lineEUCTR2013-003464-31-BEEthicon Inc210
尚未招募
不适用
To evaluate the efficacy of anti-dandruff shampoo (Dabur Vatika Germ Protection Shampoo)CTRI/2020/08/027160Dabur India Limited
已完成
不适用
A randomised, double-blind, negatively-controlled study to determine whether the use of creams or ointments could alter the sensitivity of the skin to ultraviolet light during photo-therapy with narrow band UVBISRCTN25782645Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)20
已完成
3 期
A prospective, randomized, single- blind, controlled study to investigate the effect of suplatast tosilate on early- stage idiopathic pulmonary fibrosisIdiopathic pulmonary fibrosisJPRN-UMIN000001567Hiroshima University Hospital, Department of Respiratory Medicine60