Evaluation of Brain Connectivity Function in Predicting Therapeutic Effects in Patients With Refractory Constipation: a Multicenter, Prospective, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment
研究概览
简要总结
The goal of this observational study is to identify the characteristics of brain functional connectivity in refractory constipation and fluoxetine-sensitive patients. The main questions it aims to answer are:
- Investigating the alterations in brain functional connectivity in patients with refractory constipation and fluoxetine-sensitive patients
- Assessing the predictive value of brain functional connectivity regarding the efficacy of fluoxetine and standard protocol treatments for constipation.
Participants will receive:
- Standard physiological and psychological assessments of constipation
- BOLD-fMRI tests
- Standard protocol and fluoxetine treatment
If there is a comparison group: Researchers will compare:
Refractory group/Fluoxetine sensitive group to see the specific brain alterations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18≤ age ≤ 45 years old
- •Right-handed
- •Patients diagnosed as functional constipation according to the Rome IV criteria
- •Informed consent of patients
排除标准
- •Complicated with gastrointestinal organic disease or significant functional abnormalities (tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, pelvic floor muscle relaxation, abnormal colonic transit test, etc.)
- •Long-term intense exercise (continuous exercise for more than 8 hours per week, such as marathon runners or triathletes)
- •No history of chronic pain, no recent major trauma
- •Drug abuse or tobacco dependence (half a pack or more per day)
- •Combined hypothyroidism and Parkinson's disease
- •Patients with confirmed mental illness or neurological disorders who take psychotropic drugs, analgesics or hormones
- •History of abdominal surgery (appendectomy, hysterectomy, or cholecystectomy)
- •Contraindications to functional magnetic resonance imaging (claustrophobia, metal implants)
- •Pregnant or lactating women with constipation after delivery
- •Patients with other benign and malignant tumors and autoimmune diseases
- •Infectious diseases such as hepatitis B, hepatitis C, AIDS, etc.
- •Heart disease, organ failure and other chronic diseases that require long-term medication or affect the quality of life
研究组 & 干预措施
Refractory constipation: fluoxetine sensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with effective treatment of constipation symptoms.
干预措施: BOLD-fMRI (Diagnostic Test)
Refractory constipation: fluoxetine sensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with effective treatment of constipation symptoms.
干预措施: Regular treatment of functional constipation (Drug)
Refractory constipation: fluoxetine sensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with effective treatment of constipation symptoms.
干预措施: fluoxetine (Drug)
Refractory constipation: fluoxetine insensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with ineffective treatment of constipation symptoms.
干预措施: BOLD-fMRI (Diagnostic Test)
Refractory constipation: fluoxetine insensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with ineffective treatment of constipation symptoms.
干预措施: Regular treatment of functional constipation (Drug)
Refractory constipation: fluoxetine insensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with ineffective treatment of constipation symptoms.
干预措施: fluoxetine (Drug)
Non-refractory constipation
Functional constipation patients maintained at least 3 months of continuous regular therapy with effective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
干预措施: BOLD-fMRI (Diagnostic Test)
Non-refractory constipation
Functional constipation patients maintained at least 3 months of continuous regular therapy with effective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
干预措施: Regular treatment of functional constipation (Drug)
Health Control
Volunteers without symptoms of constipation
干预措施: BOLD-fMRI (Diagnostic Test)
结局指标
主要结局
Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment
时间窗: 1-week pre and 4-week post of fluoxetine treatment
BOLD-fMRI tests before and after fluoxetine treatment
次要结局
- Changes in PAC-QOL self-assessment scores from baseline(1-week pre and 4-week post-fluoxetine treatment.)
- Changes in GAD-7 self-assessment scores from baseline.(1-week pre and 4-week post-fluoxetine treatment.)
- Changes in PHQ-15 self-assessment scores relative to baseline.(1-week pre and 4-week post-fluoxetine treatment.)
- Changes in PHQ-9 self-assessment scores since baseline.(1-week pre and 4-week post-fluoxetine treatment.)
- Changes in KESS self-assessment scores from baseline.(1-week pre and 4-week post-fluoxetine treatment.)
研究者
Zhifeng Zhao, PhD
Dr.
Xijing Hospital of Digestive Diseases