Clinical trial NCT06221722: Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation
Official title: Evaluation of Brain Connectivity Function in Predicting Therapeutic Effects in Patients With Refractory Constipation: a Multicenter, Prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Constipation - Functional
Refractory Constipation
Fluoxetine
fMRI
Brain Connectivity
Treatment Efficacy
Somatic Symptom
Mental Symptom
Keywords: fMRI
functional connectivity
refractory constipation
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary hospitals received patients from northwest of China

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 18≤ age ≤ 45 years old
* Right-handed
* Patients diagnosed as functional constipation according to the Rome IV criteria
* Informed consent of patients

Exclusion Criteria:

* 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

Primary outcomes:
measure: Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment
timeFrame: 1-week pre and 4-week post of fluoxetine treatment
Secondary outcomes:
measure: Changes in PAC-QOL self-assessment scores from baseline
timeFrame: 1-week pre and 4-week post-fluoxetine treatment.
measure: Changes in PHQ-15 self-assessment scores relative to baseline.
timeFrame: 1-week pre and 4-week post-fluoxetine treatment.
measure: Changes in GAD-7 self-assessment scores from baseline.
timeFrame: 1-week pre and 4-week post-fluoxetine treatment.
measure: Changes in PHQ-9 self-assessment scores since baseline.
timeFrame: 1-week pre and 4-week post-fluoxetine treatment.
measure: Changes in KESS self-assessment scores from baseline.
timeFrame: 1-week pre and 4-week post-fluoxetine treatment.
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia
city: Xi'an
country: China
facility: Xi'an International Medical Center Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases
name: Qingchuan Zhao, Prof.
role: STUDY_CHAIR
References: