The Use of Inulin to Prevent Dysbiosis in Pediatric Hematopoietic Stem Cell Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in alpha and beta bacterial diversity measures in stool
研究概览
简要总结
This study will look at the effect of the prebiotic inulin compared to placebo on children undergoing stem cell transplant.
详细描述
Children enrolled in the study will receive either the prebiotic inulin or a placebo for 21 days during the study period. They will start taking the product seven days before transplant starts until 14 days after transplant. Stool will be collected twice weekly until thirty days after transplant or discharge, whichever occurs first. Stool samples will be sampled for metagenomic sequencing to identify the diversity of bacteria within the stool. They will also be analyzed for amount of short-chain fatty acid content (a breakdown product of inulin) as well as for presence of genes that confer antibiotic resistance. From 30 days after transplant until 100 days after transplant, two stool samples will be collected at regularly scheduled follow up appointments (near day 60 and day 100). No product (inulin or placebo) will be given during this time frame. The study period ends 100 days after transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants will be randomized by an independent statistician based on patient enrollment number (LCH 001- LCH 040). Randomization will be 1:1. The statistician will randomly assort LCH 001-020 into Inulin/Placebo and LCH 021- LCH 040 into Inulin/placebo. This will ensure that an equal number of enrolled participants will be in each arm at 20 patients, and then again at anticipated full 40 patients
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-18 years
- •Allogeneic Stem Cell transplant
- •Myeloablative therapy
- •Inpatient at Lurie Children's Hospital
排除标准
- •Previous Hematopoietic Stem Cell Transplant
- •Autologous Stem Cell Transplant
- •Reduced Intensity Conditioning used for transplant
- •History of ulcerative colitis, Crohn's disease, irritable bowel syndrome, celiac disease
- •History of Type 1 or Type 2 Diabetes Mellitus
- •Previous abdominal surgery necessitating the use of an ostomy
- •G-tube dependence
- •Nasal gastric/oral gastric tube dependence prior to starting the conditioning process
- •Graft vs host disease prior to enrollment at any site
- •Children under 2 years of age - literature shows that the microbiome is still developing in children under two years of age, and this development may skew results
结局指标
主要结局
Change in alpha and beta bacterial diversity measures in stool
时间窗: Change of baseline alpha and beta bacterial diversity at 100 days after transplant
Compare the effect of oral inulin vs. placebo on alpha and beta bacterial diversity in the stool of children undergoing hematopoietic stem cell transplant
Change in Short Chain Fatty Acid (SCFA) levels in stool
时间窗: Change in baseline SCFA levels in stool at 100 days after transplant
Compare the effect of oral inulin vs. placebo on SCFA levels in the stool of children undergoing hematopoietic stem cell transplant
次要结局
- Bacterial Resistance genes in stool(Measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant)
研究者
Mehreen Arshad
Fellow of Pediatric Infectious Diseases
Ann & Robert H Lurie Children's Hospital of Chicago