Do Decreased Dietary Fat and Increased Fiber Reduce Recurrence of Clostridioides Difficile Infection in Oncology Patients?
概览
- 阶段
- 不适用
- 干预措施
- Diet Intervention
- 疾病 / 适应症
- Leukemia, Lymphocytic, Acute
- 发起方
- University of Colorado, Denver
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- C. difficile infection recurrence (yes/no)
- 状态
- 终止
- 最后更新
- 3个月前
概览
简要总结
The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile infection recurrence in a cohort of oncology patients.
详细描述
This is a randomized study. A total of 124 individuals with either acute leukemia or lymphoma and a first or second occurrence of C. difficile infection will be enrolled. Participants will be randomized to Arm 1 (Diet intervention) or Arm 2 (No diet intervention). Participants in Arm 1 will be assessed for food preferences and will be provided lists of high fiber and high saturated fats. Participants will be able to choose foods from the high fiber food lists and groceries will be provided once per week to support each participant's meal plan. Participants will be asked to limit foods on the high saturated fats list. Food consumption with a 24 hour recall and weight will be monitored and stool samples will be collected one time per week for 6 weeks. In Arm 2, participants will be asked to provide 24 hour food recall and stool samples. Individuals in both arms will be monitored for stool consistency and any antibiotics or chemotherapy drugs taken. Participation will last 6 weeks.
研究者
入排标准
入选标准
- •Diagnosis of a malignant neoplasm at the at Children's Hospital Colorado or the University of Colorado Hospital
- •Diagnosis of first time or first recurrent CDI as defined by clinical criteria within the past 21 days
- •Informed consent obtained and signed. For minors, the consent will be completed by a guardian and the study participant will sign the assent form. Only the consent form is required of adults.
- •9 years old or older
- •40th to 100th percentiles of saturated fat intake and below the 50th percentile for fiber intake based on a food frequency questionnaire.
- •Ability to comply with study procedures for the entire length of the study.
排除标准
- 未提供
研究组 & 干预措施
Arm 1: Diet Intervention
Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided.
干预措施: Diet Intervention
Arm 2: No Diet Intervention
No diet changes will be made for participants
结局指标
主要结局
C. difficile infection recurrence (yes/no)
时间窗: 6 months
Signs of active diarrhea using Bristol stool scale. The Bristol stool form scale includes seven types of stool which ranging from constipation (type 1) to diarrhea (type 7).
次要结局
- C. difficile toxins A and B(6 weeks)
- Fecal microbiome(6 weeks)