Mycobiome Supporting Diet (MSD) to Reduce Gastrointestinal (GI) Toxicity Associated With Autologous Stem Cell Transplant (ASCT) For Patients With Multiple Myeloma (MM)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- PRO-CTCAE questionnaire scores
研究概览
简要总结
The purpose of this study is to determine if this specific Mycobiome Supporting Diet (MSD diet) can help reduce gut inflammation during post-transplant period. The MSD is an special diet which will be explained in detail by a dietician that works by supporting the body's good gut bacteria and fungi.
详细描述
This is a non-randomized cohort study. Participants will be on a specific diet for 4 weeks prior to transplant and 10 days after transplant, and will then be asked to fill out several questionnaires during this period to see if this diet is easy and simple to follow. The questionnaires will be weekly while participants are outpatient and once admitted to the hospital, participants will need to fill it on the last day (10 days after stem cell infusion). Participants will also be requested to provide fecal swab samples which we will test for bacteria and fungi. A total of 3 samples will be taken at different time points during this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for first autologous transplant for myeloma
- •Willing to adhere to the allowed and disallowed foods of the diet plan.
- •Able to get and prepare their own food items for all meals during the study
排除标准
- •Active inflammatory bowel disease, celiac disease, other chronic intestinal disorders
- •Pregnant women, planning to get pregnant or breastfeeding
- •Prior bowel resection
- •Inability to tolerate the study diet due to allergies/ intolerance/ preference
- •Inability to consent to trial
- •Patients with restrictions in diet including inability to have oral nutrition with regular consistency
- •Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.
- •Patients with absolute neutrophil count (ANC) < 1000 on long term antibacterial prophylaxis ongoing 3 days prior to enrollment
- •Patients who received antifungal therapy in 3 days prior to enrollment
- •Patients who received steroid therapy in 7 days prior to enrollment
结局指标
主要结局
PRO-CTCAE questionnaire scores
时间窗: week 4 in the 1 month prior to transplant
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
时间窗: 7 days prior to transplant (an average of 1 month from start of study)
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Patient-reported outcome (PRO)-Common Terminology Criteria for Adverse Even CTCAE questionnaire
时间窗: After baseline (7 days post-transplant)
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
次要结局
未报告次要终点