Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Shannon Index
研究概览
简要总结
The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis with the additive or synergistic effects of the combination of vitamin D + inulin.
详细描述
Cystic fibrosis (CF) is the most common life-shortening genetic condition among Caucasians in the United States. Individuals with CF have an altered gastrointestinal (GI) microbiota, which may be a result of chronic systemic inflammation and infection, frequent use of antibiotics, and/or medically prescribed and habitual high-fat/high-calorie diets.
The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •male and female patients (age > 18 years) with confirmed CF by genetic mutation and/or sweat chloride testing,
- •not currently on oral or systemic antibiotics for pulmonary exacerbation,
- •vitamin D deficient/insufficient (25(OH)D, 6 - 30 ng/mL) with most recent 25(OH)D in the past 12 months,
- •use of CFTR modulator therapy is allowed
排除标准
- •severe vitamin D deficiency 25(OH)D ≤ 5 ng/mL or hypocalcemia or hypercalcemia,
- •active GI disease, abdominal pain and/or diarrhea,
- •chronic kidney disease worse than stage 3 (eGFR < ml/min per 1.73 m2),
- •any vitamin D supplement use >2,000 IU or vitamin D analogue (patients who are taking more than 2,000 IU of vitamin D must agree to stop the vitamin D for 6 weeks and take less than 2,000 IU of vitamin D during the study),
- •use of immunosuppressants or history of organ transplantation,
- •current use of probiotics or prebiotics
研究组 & 干预措施
Vitamin D3 and Inulin
Vitamin D3 50,000 IU/week and 12 g/day chicory-derived prebiotic inulin for 12 weeks
干预措施: Vitamin D3 (Drug)
Vitamin D3 and Inulin
Vitamin D3 50,000 IU/week and 12 g/day chicory-derived prebiotic inulin for 12 weeks
干预措施: Inulin (Drug)
Vitamin D3 and placebo Inulin
Vitamin D3 50,000 IU/week and 12 g/day corn-derived maltodextrin/day as the prebiotic placebo for 12 weeks
干预措施: Vitamin D3 (Drug)
Vitamin D3 and placebo Inulin
Vitamin D3 50,000 IU/week and 12 g/day corn-derived maltodextrin/day as the prebiotic placebo for 12 weeks
干预措施: Placebo Inulin (Drug)
Placebo vitamin D3 and Inulin
Matching to Vitamin D3 placebo capsules, and 12 g/day chicory-derived prebiotic inulin for 12 weeks
干预措施: Placebo vitamin D3 (Drug)
Placebo vitamin D3 and Inulin
Matching to Vitamin D3 placebo capsules, and 12 g/day chicory-derived prebiotic inulin for 12 weeks
干预措施: Inulin (Drug)
Placebo vitamin D3 and placebo Inulin
Matching to Vitamin D3 placebo capsules, and 12 g/day corn-derived maltodextrin/day as the prebiotic placebo for 12 weeks
干预措施: Placebo vitamin D3 (Drug)
Placebo vitamin D3 and placebo Inulin
Matching to Vitamin D3 placebo capsules, and 12 g/day corn-derived maltodextrin/day as the prebiotic placebo for 12 weeks
干预措施: Placebo Inulin (Drug)
结局指标
主要结局
Shannon Index
时间窗: Baseline, 12 weeks post-intervention
The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community. Sputum microbiota analysis was measured using this ecological diversity measure. Sputum samples were collected via a sputum kit.
Change in Species Richness Index From Baseline
时间窗: Baseline, 12 weeks post-intervention
Stool microbiota analysis will be measured using this ecological diversity measure. Stool samples will be collected using a stool kit provided to the participant.
次要结局
- Change in GI Microbiota Richness(Baseline, 12 weeks post-intervention)
- Change in GI Microbiota Diversity(Baseline, 12 weeks post-intervention)
- Change in GI Microbiota Composition(Baseline, 12 weeks post-intervention)
研究者
Vin Tangpricha
Principal Investigator
Emory University