ACTRN12619000150145尚未招募未知
Influence of Extra Virgin Olive Oil intake on Disease Activity and Gut Microbiota Profile of Community Dwelling Adults with Ulcerative Colitis in Comparison to Healthy Subjects
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 56
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •For Individuals with Ulcerative Colitis:
- •1) Aged >= 18 at the time of recruitment
- •2) Ulcerative colitis (UC) >3 months duration of any extent .
- •3) Willingness to participate in the study protocol, randomization and provide informed consent
- •For non-IBD subjects:
- •1) Aged >= 18 years at the time of recruitment
- •2.) Willing to be randomized into one of the two study arms and participate in the intervention prescribed
- •3) Stable medication. All drugs to be held at constant dose during the study and no changes to medication in the preceding 4 weeks.
排除标准
- •For individuals with Ulcerative Colitis (UC)
- •1) Currently living with other Inflammatory Bowel Disease not defined as UC (e.g. Crohn's disease, non specific IBD)
- •2) History of fecal microbiota transplantation
- •3) Significant prior gastrointestinal surgery (e.g., colon resection, colectomy) or clinical evidence of any comorbid chronic disease that may interfere with the patient’s ability to enter the trial and undertake the testing
- •4) Planned major surgery within the first 3 months after randomization
- •5) Antibiotic/anti-tuberculosis treatment for any reason during the study period or in the preceding 4 weeks
- •6) Changes to UC medical therapy within 4 weeks of study initiation
- •7) Pregnant or female planning pregnancy for the first 3 months post randomisation
- •8) Diagnosed allergy or intolerance towards olives or olive based products, or avoidance of olive based products for any other reason
- •9) Daily consumption of olives or olive based products including spreads, oils, marinated olives, tapenade, or supplements such as olive leaf extract
- •10) Those undertaking a specialized diet in which the intervention would be deemed inappropriate (e;g;, fat reduction or low fat diet) or those whose diet is currently under the supervision of a relevant medical professional
- •11) Medical nutrition therapy under supervision of a healthcare professional (e.g., texture modifciation, progression to a full diet post hospitaliation, FODMAP or RPA elimination diet challenge phase)
- •12) Use of tube or enteral feeding, elemental diet, or parenteral nutrition within 4 weeks of study initiation.
- •13) Regular consumption of takeaway or restaurant meals more than 3 days a week or 9 meals a week..
- •14) Participation in another clinical trial for with concurrent participation is deemed inappropriate.
- •For participants in the non-IBD group:
- •1) History of Inflammatory Bowel Disease of any description (including remission)
- •2) History of fecal microbiota transplantation
- •3) Significant prior gastrointestinal surgery (e.g., colon resection, colectomy) or clinical evidence of any comorbid chronic disease that may interfere with the patient’s ability to enter the trial and undertake the testing
- •4) Planned major surgery within the first 3 months after randomization
- •5) Antibiotic/anti-tuberculosis treatment for any reason during the study period or in the preceding 4 weeks
- •6) Changes to UC medical therapy within 4 weeks of study initiation
- •7) Pregnant or female planning pregnancy for the first 3 months post randomisation
- •8) Diagnosed allergy or intolerance towards olives or olive based products, or avoidance of olive based products for any other reason
- •9) Daily consumption of olives or olive based products including spreads, oils, marinated olives, tapenade, or supplements such as olive leaf extract
- •10) Those undertaking a specialized diet in which the intervention would be deemed inappropriate (e;g;, fat reduction or low fat diet) or those whose diet is currently under the supervision of a relevant medical professional
- •11) Medical nutrition therapy under supervision of a healthcare professional (e.g., texture modifciation, progression to a full diet post hospitaliation, FODMAP or RPA elimination diet challenge phase)
- •12) Use of tube or enteral feeding, elemental diet, or parenteral nutrition within 4 weeks of study initiation.
- •13) Regular consumption of takeaway or restaurant meals more than 3 days a week or 9 meals a week..
- •14) Participation in an
研究者
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