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.
18≤ age ≤ 45 years old
Right-handed
Patients diagnosed as functional constipation according to the Rome IV criteria
Informed consent of patients
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)
tertiary hospitals received patients from northwest of China
Cohort
Prospective
BOLD-fMRI
Diagnostic testBlood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging
Regular treatment of functional constipation
Drugat least 3 months of continuous regular treatment. This treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
fluoxetine
DrugFluoxetine oral treatment for 4 weeks.
Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment
BOLD-fMRI tests before and after fluoxetine treatment
Changes in PAC-QOL self-assessment scores from baseline
The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire is a self-reported instrument designed to measure the quality of life in individuals with constipation. This tool comprises 28 items across four fundamental domains, including physical discomfort, worries and concerns, psychosocial discomfort, and satisfaction. In our study, the Chinese version (version 16) was utilized.
Changes in PHQ-15 self-assessment scores relative to baseline.
The Patient Health Questionnaire-15 (PHQ-15) is a self-reporting inventory that evaluates the severity of somatic symptoms in patients. Comprising 15 items, the questionnaire primarily focuses on experienced bodily symptoms and aids healthcare providers in identifying potential somatization disorders or severe somatic illnesses.
Changes in GAD-7 self-assessment scores from baseline.
The Generalized Anxiety Disorder-7 (GAD-7) is a brief measure assessing the frequency of anxiety symptoms over the past two weeks. With 7 items, the scale concentrates on the core symptoms of generalized anxiety disorder, serving as an instrument to ascertain the level of anxiety and to monitor the improvement of anxiety symptoms.
Changes in PHQ-9 self-assessment scores since baseline.
The Patient Health Questionnaire-9 (PHQ-9) is a tool used for screening, diagnosing, monitoring, and quantifying the severity of depression. The questionnaire consists of 9 items drawing from typical symptoms of depression, facilitating the evaluation of the presence and severity of depression by medical professionals.
Click on the lead sponsor to view all of their trials.
