Oligosaccharide for Cdiff(+) Heme-onc Patients
關鍵詞
抽象
描述
Aim 1/Objective 1. Establish the feasibility of oligosaccharide supplementation and twice a week stool collections among 12 C. difficile colonized hematology-oncology inpatients. It will be determined if at least 70% of the oligosaccharide dosages are taken by at least 8 (>=66%) of the 12 enrolled patients. Additionally, the ability to collect at least 50% of the scheduled stool samples will be evaluated.
Aim 1 will provide important information about the ideal food/drink to mix the potato starch supplemented in this study. The knowledge gained in this pilot will be used to design a future phase II or III clinical trial.
Aim 2. Explore the impact of oligosaccharide supplementation on C. difficile loads and relative abundance of Firmicutes. All stool samples will undergo 16S ribosomal ribonucleic acid (rRNA) and bioinformatics at the MCW's Genomic and Precision Medicine Center and C. difficile quantitative polymerase chain reaction (qPCR) at the PI's research laboratory. Historical controls will be obtained from a group of over 450 hematology-oncology inpatients who underwent at least one C. difficile surveillance test and whose stool samples are currently being processed for 16S rRNA by the PI's team. Controls at a 3:1 ratio with cases will be matched based on underlying disease, unit of admission, antibiotic use, baseline C. difficile fecal loads, and baseline relative abundance of Firmicutes.
Objective 2a. Evaluate the impact of oligosaccharide supplementation on the change of C. difficile fecal loads when compared to historical controls.
Objective 2b. Explore the effect of oligosaccharide supplementation on the change in relative abundance of Firmicutes when compared to historical controls.
It is expected a reduction will occur in C. difficile fecal loads during oligosaccharide supplementation when compared to matched controls. Conversely, it is expected an increase in the relative abundance of Firmicutes (or some of its operational taxonomic units; OTUs) during oligosaccharide replacement will occur when compared to matched controls. The knowledge gained with Objectives 2a and 2b will be used to determine the sample size needed to design future phase II or phase III clinical trials.
日期
| 最後驗證: | 11/30/2019 |
| 首次提交: | 11/29/2018 |
| 提交的預估入學人數: | 12/13/2018 |
| 首次發布: | 12/18/2018 |
| 上次提交的更新: | 12/08/2019 |
| 最近更新發布: | 12/10/2019 |
| 實際學習開始日期: | 05/31/2019 |
| 預計主要完成日期: | 05/31/2020 |
| 預計完成日期: | 06/30/2020 |
狀況或疾病
干預/治療
Dietary Supplement: Potato starch supplementation
相
手臂組
| 臂 | 干預/治療 |
|---|---|
| Experimental: Potato starch supplementation Twelve patients found to be colonized with C. difficile will undergo twice a day potato starch supplementation. | Dietary Supplement: Potato starch supplementation Potato starch will be given twice a day for up to 14 days, discharge, or death, whichever occurs first. |
資格標準
| 有資格學習的年齡 | 18 Years 至 18 Years |
| 有資格學習的性別 | All |
| 接受健康志願者 | 是 |
| 標準 | Inclusion Criteria: Patients must meet all inclusion criteria to be eligible to participate in the study. - Patients must be at least 18 years of age at time of consent. - Positive C. difficile surveillance test. - Absence of diarrhea or abdominal pain within the past 48 hours. - Patient admitted in a hematology-oncology unit which for the purposes of this study will be defined as 7-CFAC and 8-CFAC. Exclusion Criteria: Patients must NOT meet any exclusion criteria to be eligible to participate in the study. - Presence of >= grade I nausea/vomiting. - Inability to take oral medications or food. - Expected length of hospitalization or survival less than 5 days - Patient is only boarding in hematology-oncology units and would have not otherwise been admitted to these units. - Unwillingness or inability to provide written informed consent. - Women known to be pregnant or lactating during the study. - History of inflammatory bowel disease. |
結果
主要結果指標
1. Stool samples will be collected twice a week while on potato starch supplementation and 1 time at 7-days post- starch supplementation to assess any changes in the frequency of collection during the 21-day period. [Day 1- Day 21]
2. Oligosaccharide intake assessed by a patient diary to measure supplementation feasibility [Day 1-Day 14]
3. The feasibility of collecting all available stool samples stool will be assessed. A rate ≥50% of correctly collected and processed samples will be considered feasible. [Day 1-Day 14]
次要成果指標
1. Changes in C. difficile loads will be assessed using C. difficile quantitative polymerase chain reaction (qPCR). [Day 1-Day 14]
2. Changes in Firmicutes' relative abundance due to oligosaccharide supplementation measured by 16S rRNA gene sequencing [Day 1-Day 14]
