Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD(Study 2).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pediatric Quality of Life: scale
研究概览
简要总结
This prospective, randomized, longitudinal, controlled study will enroll pediatric CD patients with inflammatory, non-stricturing, and non-penetrating disease type with mild/quiescent disease based on Pediatric Crohn's Disease Activity Index (PCDAI). Participants will be randomized to receive HRV biofeedback intervention daily for 12 weeks or to music relaxation therapy.
详细描述
The inflammatory bowel diseases (IBD), which include Crohn's disease (CD) and ulcerative colitis (UC), affects 3 million Americans. In approximately 25-30% of patients, onset of these chronic diseases occurs prior to the age of 20. Despite medical advances in new therapies, the clinical remission rate on biologics is less than 50% and a significant number of patients will lose response to anti-TNF therapy over time. In addition, patients that require a change in therapy will have a lower response rate to a different biologic. Additional therapies and mechanisms that affect disease activity need to be investigated to identify complimentary treatments that can further impact remission rates without increasing side effects such as lymphoma.
Environmental factors, such as stressor exposure, can exacerbate mucosal inflammation. Patients with IBD report a lower quality of life, as well as increased anxiety and depression. Psychological interventions may improve disease activity. This study will test, using a randomized clinical trial (RCT) design, whether biofeedback intervention will attenuate disease activity. If efficacious, this study will provide a rationale for establishing biofeedback as a complimentary therapy to standard of care to ameliorate stress-induced increases in chronic inflammation.
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
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-17 years
- •Have inflammatory, non-stricturing, and non-penetrating CD with either mild/quiescent disease based on PCDAI or PGA
- •Live within a 2 hour drive of NCH
排除标准
- •Participants are excluded if they have ulcerative colitis, penetrating and/or stricturing CD, have a comorbid chronic illness, perianal disease, taking antibiotics within the last 3 months, psychological disorders that they are undergoing treatment or taking medication for at that time, presence of a heart rhythm or other abnormality of heart rhythm on screening EKG, or undergoing psychological treatments such as cognitive behavioral therapy, mindfulness, or biofeedback therapy at the time of enrollment.
- •Age and language are limited by the demands of the study (questionnaire completion
结局指标
主要结局
Pediatric Quality of Life: scale
时间窗: enrollment to 12 month follow up
PedsQL. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.
Disease activity( Fecal calprotectin)
时间窗: enrollment to 12 month follow up
Fecal calprotectin levels from stool
Anxiety
时间窗: enrollment to 12 month follow up
PROMIS Pediatric Anxiety Short Form. Scores range from 0-60, with higher scores indicating higher levels of anxiety. Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.
Depression
时间窗: enrollment to 12 month follow up
Children's Depression Inventory short form. Scores range from 0-54, with higher scores indicating higher levels of depression. Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.
Disease Activity (Crohn's disease)
时间窗: enrollment to 12 month follow up
Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up. Higher scores indicate more severe disease. Scores range from 0-100.
Stress
时间窗: enrollment to 12 month follow up
PROMIS Pediatric Psychological Stress Experiences.Scores range from 0-60, with higher scores indicating higher levels of stress.Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.
次要结局
- Stress-related changes in the microbiome(enrollment to 12 month follow up)
- Stress-related changes in the metabolome.(enrollment to 12 month follow up)
研究者
Ross Maltz
Principal Investigator
Nationwide Children's Hospital