Effect of Curcumin Food Supplement on Gut Microbiota in Children With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Alteration in Gut Microbiota
研究概览
简要总结
To evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome (IBS) and to review any correlation between the changes in the microbiota with symptoms.
详细描述
This is a prospective, placebo-controlled, double blinded, randomized control trial. This study will evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome. Curcumin is a commonly used spice in Asian cooking and has a very good safety profile. Developing preparation of this compound for targeted delivery in the GI tract would provide a novel way to treat common FGID. This study will provide preliminary data for future studies to evaluate the role of gut microbiota in the pathophysiology of pain predominant FGID and how food supplements can be used to manipulate the microbiota.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 to 18 years old
- •Fulfill the Rome IV criteria for diarrhea predominant IBS
- •English speaking
- •Able to swallow curcumin/placebo capsules
排除标准
- •Weigh less than 35 kg
- •On any form of dietary restrictions
- •Taken probiotics one month before enrollment
- •Antibiotic treatment one month before enrollment
- •Celiac disease
- •Peptic ulcer disease
- •H. Pylori gastritis
- •Abnormality of gastrointestinal tract
- •Previous abnormal endoscope
- •Previous abdominal surgeries
- •Gall stones
- •Biliary tract obstructions
- •Liver pathologies
- •Liver failure
- •Active GI infection
- •Positive stool cultures
- •Drug or alcohol abuse
- •Concomitant immunological/hematological/neoplastic/heart/ renal/pulmonary condition
- •Any other medical condition or taking any form of drug(s) which can explain the current symptoms
- •Take oral or intravenous drugs which could have potential drug interaction with curcumin
- •Lactating or pregnant or planning to become pregnant
- •Developmental delay
- •Parents that are developmentally delayed
- •Have a diet high in curcumin/turmeric
研究组 & 干预措施
Placebo
Patients in the placebo arm will receive a capsule which has similar size, shape and color of the curcumin capsule. The placebo capsule will contain inert food powder. Study duration will be 8 weeks.
干预措施: Placebo (Dietary Supplement)
Treatment
Patients in the treatment arm with weight between 35 kg to 50 kg will receive 50 mg capsule of curcumin twice a day (maximum dose 2.8 mg/kg/day, which is within the GRAS approved dose) and those over 50 kg in weight will receive three curcumin capsules a day (maximum dose 3 mg/kg/day, within GRAS recommended dose). Study duration will be 8 weeks.
干预措施: Curcumin (Dietary Supplement)
结局指标
主要结局
Alteration in Gut Microbiota
时间窗: 8 weeks
To study the alteration in gut microbiota with 8-week curcumin dietary supplementation in children with IBS between the ages of 10 yrs to 18 yrs
次要结局
- Comparison of GI Symptoms(8 weeks)
研究者
Manu Sood
Principal Investigator
Medical College of Wisconsin