Effect of Gum Arabic on Gastrointestinal Transit and Permeability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Colonic Transit time
研究概览
简要总结
The study aims to determine the effect of gum arabic on gut bacteria and GI function.
详细描述
To compare the effect of placebo, low-dose prebiotic, or high-dose prebiotic on gut microbiota composition and function, GI transit and permeability, and assess development of symptoms or a change in pre-existing symptoms present, in patients with recent history of clinically diagnosed diverticulitis which has been successfully treated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent diagnosis of diverticulitis (within 24 months) and at least 4 weeks post antibiotic use
排除标准
- •Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
- •Known diagnosis of inflammatory bowel disease (Crohn's or ulcerative colitis), microscopic colitis, celiac disease, or other inflammatory condition other than diverticulitis
- •Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- •Use of NSAIDs or aspirin within the week prior to Visit 2 and Visit 5 (permeability and transit testing visit since NSAIDs affect intestinal permeability)
- •Use of osmotic laxatives one week prior to Visit 2 and for the duration of the study
- •Use of oral corticosteroids within the previous 6 weeks and for the duration of the study
- •Ingestion of artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages
- •Antibiotic use within 4 weeks of completion of the initial stool kit and/or Visit 2 testing appointment and for the remainder of the study (they can complete the stool kit and Visit 2 after a 4-week washout period)
- •Bowel preparation for colonoscopy less than one week prior to the completion of the first stool kit and Visit 2 and during the remainder of the study
- •Pregnancy or plan to become pregnant within the study timeframe
- •Vulnerable adults
- •Egg allergy or resistant to ingesting eggs
- •Diagnosis of diabetes
- •Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
结局指标
主要结局
Colonic Transit time
时间窗: Change is being assessed between baseline and 6 weeks
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. Units: units on a scale
次要结局
- Intestinal Permeability(Change is being assessed between baseline and 6 weeks)
研究者
Purna C. Kashyap, MBBS
Principal Investigator
Mayo Clinic