The MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 194
- 试验地点
- 3
- 主要终点
- Change in overall number of proteobacteria
研究概览
简要总结
The MELODY Trial: Modulating Early Life Microbiome through Dietary Intervention in Crohn's Disease, will test whether a non-invasive dietary intervention during pregnancy can improve the gut microbiota composition in both pregnant Crohn's disease patients and their babies during the sensitive time window of infant immune system development, and whether this can lead to decreased risk of maternal disease relapse postpartum and decreased functional gastrointestinal disorders and gut inflammation in their babies. Through this trial, the study team hopes to better understand the origin of the initial gut bacterial colonization in babies, providing potential intervention targets to prevent Crohn's disease development in high risk individuals.
详细描述
The study design is a three-arm, prospective, pre-post intervention trial. Crohn's Disease (CD) patients at 27-29 weeks of pregnancy will self-select to Arm 1 or Arm 2. Controls will be in Arm 3.
- Arm 1 (diet-CD): 8-10 weeks of dietary intervention (n=66)
- Arm 2 (no-diet-CD): usual diet with no diet intervention (n=66)
- Arm 3 (no-diet-control): unaffected controls at the same gestational stage will follow their usual diet and no intervention (n=66).
The goal of this study is to prospectively test the hypothesis that a non-invasive dietary intervention during the last trimester of pregnancy could beneficially shift the microbiome of CD patients and their babies, hereby promoting a healthier immune system during a critical time of the immune system development. Particularly, the study team will test whether favorable diet-driven changes in the microbiome can lead to a reduced risk of postpartum relapse and lower gut inflammation in the offspring.
Stool, saliva, breast milk and umbilical cord blood samples will be collected, and questionnaires administered. Self-selected participants to Arm 1 will adopt a specified diet, which will be adapted to address specific needs of third trimester pregnancy without compromising the diet principles. Subjects will receive nutritional counseling and training, and compliance to dietary recommendations will be recorded.
Analysis will be performed to correlate dietary change and assessed changes in quality of life with microbial composition in the gut and with circulating markers of inflammation in moms. The study team will also compare the effect of diet vs. non-diet on babies' microbiome and the impact of the early life microbiome in levels of inflammatory markers after 1-year of partum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- Female
- 接受健康志愿者
- 是
入选标准
- •Capacity to sign informed consent
- •At least 18 years old
- •Singleton pregnancy of less than 27-29 weeks gestation
- •English-speaking
排除标准
- •Inability to provide informed consent
- •Multi-fetus pregnancy
- •Fetal chromosomal or structural abnormalities
- •Active infection (including chorioamnionitis or sepsis)
- •Alcohol use disorder
- •Diagnosis of diabetes, renal disease, or intrauterine growth restriction
- •Non-English speaking
- •Active perianal or extraintestinal disease
- •Antibiotic or steroid treatment at recruitment
- •Scheduled cesarean section prior to gestational week 37
结局指标
主要结局
Change in overall number of proteobacteria
时间窗: Baseline and 4 Years
Change in overall number of proteobacteria in pregnant CD patients at 4 years as compared to baseline
次要结局
- SF-12(4 Years)
- Calprotectin level(4 Years)
- Harvey Bradshaw index (HBI)(4 Years)
- The Bristol Stool Form Scale(4 Years)
- Alternative Healthy Eating Index(4 Years)
- The Rome IV Criteria(3 months)
- The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)(4 Years)
研究者
Inga Peter
Professor
Icahn School of Medicine at Mount Sinai