axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in People With Axial Spondyloarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in faecal butyrate at 2 weeks on a PEN diet
研究概览
简要总结
People with axial spondyloarthritis (axSpA) often have intestinal inflammation and intestinal microbiome dysbiosis, with some similarities to Crohn's-like inflammatory bowel disease (IBD) gut inflammation. However, research has not addressed whether Partial Enteral Nutrition (PEN), a diet formed of a liquid formula and some solid whole foods, which is effective at inducing remission in IBD, may influence the dysbiotic microbiome and inflamed, hyperpermeable intestine of axSpA patients, and whether these changes may be accompanied by alterations in systemic markers of inflammation. Thus, there is a need to determine the effects of PEN on these aspects in axSpA patients.
In this study, the investigators intend to trial a 2-week course (with optional additional 2-week extension) of a PEN diet in people with active axSpA disease. A group of healthy volunteers following the same diet will act as a control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •. Participants will fulfil ALL of the following:
- •Diagnosis of axSpA (fulfilling the ASAS criteria)
- •Active disease (BASDAI score ≥4) on day of study visit
- •Stable on treatment [defined as (1) no major change to therapy (change in treatment type) in the preceding 3 months AND (2) no minor change in therapy (adjustment of treatment dosage) in the preceding 1 month]
- •Age ≥ 16 years
- •Willing and able to give informed written consent.
- •Exclusion. Participants will have NONE of the following:
- •Pregnancy or breastfeeding
- •Prior diagnosis of IBD
- •Recipient of chemotherapy/immunotherapy/radiotherapy in prior 3 months
- •Recent systemic antibiotic use (within last 1 month)
- •Current eating disorder
- •Food allergy incompatible with diet (e.g. cow's milk allergy)
- •Following a vegan diet
- •Major surgery in prior 3 months or planned in forthcoming 3 months.
- •Unable or unwilling to give informed consent
- •Unable or unwilling to try the PEN diet.
- •Eligibility Criteria for Healthy Volunteer Participants
- •Inclusion criteria. Participants will fulfil ALL of the following:
- •Age ≥ 16 years
- •Current student and/or staff member at the University of Glasgow
- •Willing and able to give informed written consent
- •Exclusion. Participants will have NONE of the following:
- •Pregnancy or breastfeeding
- •Prior diagnosis of an immune-mediated inflammatory condition
- •Recipient of chemotherapy/immunotherapy/radiotherapy in prior 3 months
- •Recent systemic antibiotic use (within last 1 month)
- •Current eating disorder
- •Food allergy incompatible with diet (e.g. cow's milk allergy)
- •Following a vegan diet
- •Major surgery in prior 3 months or planned in forthcoming 3 months.
- •Unable or unwilling to give informed consent
- •Unable or unwilling to try the PEN diet.
排除标准
- 未提供
研究组 & 干预措施
Axial Spondyloarthritis
干预措施: Partial enteral nutrition (Dietary Supplement)
Healthy Volunteers
干预措施: Partial enteral nutrition (Dietary Supplement)
结局指标
主要结局
Change in faecal butyrate at 2 weeks on a PEN diet
时间窗: 2 weeks
次要结局
未报告次要终点