A Pilot Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease: The ALLAY Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Changes in abdominal pain from baseline at 3, 6, 9, and 12 months will be assessed using questionnaires
研究概览
简要总结
To characterize persistent abdominal pain in children with inflammatory bowel disease (IBD) by examining factors such as disease type, activity and location, psychosocial factors, and genetics.
The investigators hypothesize that by using patient pain and psychological assessments in addition to analysis of blood, stool and colonic biopsies, we can better characterize factors that predispose children and adolescents with IBD to have persistent and/or disproportionate abdominal pain.
详细描述
This is a prospective longitudinal inception cohort pilot study. The study will hopefully provide information about why there is persistent abdominal pain in children with IBD by examining factors such as disease type, activity and location, psychosocial factors, and genetics. Fifty newly diagnosed pediatric IBD patients, age 8-17 years will be enrolled into the study. There will be 2 control groups as well: pain control population: 20 patients with irritable bowel syndrome (IBS) or functional abdominal pain (FAP) diagnosis who have no evidence of bowel inflammation will serve as a pain control population for patients with no active inflammation. To serve as a control population for patients with no abdominal pain or inflammation, the investigators will include 10 patients with no gastrointestinal symptoms, who undergo colonoscopy for various reasons such as painless rectal bleeding, polyp surveillance, etc. The investigators anticipate completing enrollment in 12 months and allowed another 12 months for follow-up.
The study participants will be seen every 3 months for a year and they will have the following procedures/test performed:
- Standard of care blood and stool samples
- Pediatric Ulcerative Colitis Activity Index (PUCAI) or Pediatric Crohn's Disease Activity Index (PCDAI)
They will have an endoscopy performed at diagnosis then at 12 months from enrollment.
A magnetic resonance enterography (MRE) will be done at diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 8 years or < 18 years (achieved 8th birthday but not yet their 18th birthday)
- •IBD established by standard criteria
- •Anticipated availability for follow up for ≥ 1 year
- •Informed consent/assent
排除标准
- •Prior abdominal surgery unrelated to IBD
- •Active gastrointestinal infection at time of diagnosis (e.g., C. difficile)
- •Other co-morbidities that contribute to abdominal pain (e.g., Familial Mediterranean Fever, metabolic disease)
- •Preexisting chronic pain disorder (e.g., fibromyalgia)
结局指标
主要结局
Changes in abdominal pain from baseline at 3, 6, 9, and 12 months will be assessed using questionnaires
时间窗: Assessed at baseline then at months 3, 6, 9, and 12
Changes in abdominal pain from baseline then assessed again at 3, 6, 9, and 12 months.
次要结局
未报告次要终点
研究者
Victoria Grossi
Pediatric Fellow/GI Department
Connecticut Children's Medical Center